biosigtech.comPure EP
BioSig Technologies
BIOSIG TECHNOLOGIES
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015422813 | 3015422813 | BIOSIG TECHNOLOGIES | 1 | N | 2020-04-25 | 12424 Wilshire Blvd Suite 745 Los Angeles CA US 90025 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00856750007109 | Pure EP - 5 x Single Jumper Cable Black 0.3m - 5 cables in one bag with single jumper cables black to split ECG signals between two ECG devices is an accessory to the PURE EP System.The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit),and the personal computer (PC), which are connected over a highspeedfiber optic cable. The patient is connected to the amplifier viaa set of supplied ECG cables and commercially availableintracardiac (IC) catheters. The amplifier includes hardware andembedded software necessary for acquiring ECG and IC signalsfrom patients. The device is not intended for active patientmonitoring. It consists of one ECG and seven IC modules designedto acquire 12-lead ECG and 56 IC signals and send the digitizeddata to the PC. The PC has preinstalled PURE-EP software and isconnected to display monitors. The pre-installed software providesvisualization of received data from the amplifier on real-time andreview screens. It also includes a signal processing module thatprovides various filter options for real-time and review screens. | 1-203-409-5444 | eriechert@biosigtech.com |
| 00856750007116 | Pure EP - 5 x Single Jumper Cable Black 0.1m - 5 cables in one bag with single jumper cables black to split ECG signals between two ECG devices is an accessory to the PURE EP System.The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit),and the personal computer (PC), which are connected over a highspeedfiber optic cable. The patient is connected to the amplifier viaa set of supplied ECG cables and commercially availableintracardiac (IC) catheters. The amplifier includes hardware andembedded software necessary for acquiring ECG and IC signalsfrom patients. The device is not intended for active patientmonitoring. It consists of one ECG and seven IC modules designedto acquire 12-lead ECG and 56 IC signals and send the digitizeddata to the PC. The PC has preinstalled PURE-EP software and isconnected to display monitors. The pre-installed software providesvisualization of received data from the amplifier on real-time andreview screens. It also includes a signal processing module thatprovides various filter options for real-time and review screens. | 1-203-409-5444 | eriechert@biosigtech.com |
| 00856750007130 | Pure EP - 5 x 10 pin Yoked Jumper Cable White - 5 cables in one bag with 10 pin yoked jumper cables yellow to split ECG signals between two ECG devices is an accessory to the PURE EP System.The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit),and the personal computer (PC), which are connected over a highspeedfiber optic cable. The patient is connected to the amplifier viaa set of supplied ECG cables and commercially availableintracardiac (IC) catheters. The amplifier includes hardware andembedded software necessary for acquiring ECG and IC signalsfrom patients. The device is not intended for active patientmonitoring. It consists of one ECG and seven IC modules designedto acquire 12-lead ECG and 56 IC signals and send the digitizeddata to the PC. The PC has preinstalled PURE-EP software and isconnected to display monitors. The pre-installed software providesvisualization of received data from the amplifier on real-time andreview screens. It also includes a signal processing module thatprovides various filter options for real-time and review screens. | 1-203-409-5444 | eriechert@biosigtech.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 228211 | 1436821922 | K180805 | Pure EP | DQK | 2018-08-08 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DQK | 1 | 2018-08-08 |
PMN#
GUDID#
Pure EP - PURE EP™ is a system consists of two main parts: the amplifier,and the personal computer (PC), which are connected over a highspeedfiber optic cable. The patient is connected to the amplifier viaa set of supplied ECG cables and commercially availableintracardiac (IC) catheters. The amplifier includes hardware andembedded software necessary for acquiring ECG and IC signalsfrom patients. The device is not intended for active patientmonitoring. It consists of one ECG and seven IC modules designedto acquire 12-lead ECG and 56 IC signals and send the digitizeddata to the PC. The PC has preinstalled PURE-EP software and isconnected to display monitors. The pre-installed software providesvisualization of received data from the amplifier on real-time andreview screens. It also includes a signal processing module thatprovides various filter options for real-time and review screens.
2021-01-20
Pure EP - 5 x 4 pin Yoked Jumper Cable Red - 5 cables in one bag with 4 pin yoked jumper cables red to split ECG signals between two ECG devices is an accessory to the PURE EP System.The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit),and the personal computer (PC), which are connected over a highspeedfiber optic cable. The patient is connected to the amplifier viaa set of supplied ECG cables and commercially availableintracardiac (IC) catheters. The amplifier includes hardware andembedded software necessary for acquiring ECG and IC signalsfrom patients. The device is not intended for active patientmonitoring. It consists of one ECG and seven IC modules designedto acquire 12-lead ECG and 56 IC signals and send the digitizeddata to the PC. The PC has preinstalled PURE-EP software and isconnected to display monitors. The pre-installed software providesvisualization of received data from the amplifier on real-time andreview screens. It also includes a signal processing module thatprovides various filter options for real-time and review screens.
2022-02-07
Pure EP - 5 x 4 pin Yoked Jumper Cable Yellow - 5 cables in one bag with 4 pin yoked jumper cables yellow to split ECG signals between two ECG devices is an accessory to the PURE EP System.The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit),and the personal computer (PC), which are connected over a highspeedfiber optic cable. The patient is connected to the amplifier viaa set of supplied ECG cables and commercially availableintracardiac (IC) catheters. The amplifier includes hardware andembedded software necessary for acquiring ECG and IC signalsfrom patients. The device is not intended for active patientmonitoring. It consists of one ECG and seven IC modules designedto acquire 12-lead ECG and 56 IC signals and send the digitizeddata to the PC. The PC has preinstalled PURE-EP software and isconnected to display monitors. The pre-installed software providesvisualization of received data from the amplifier on real-time andreview screens. It also includes a signal processing module thatprovides various filter options for real-time and review screens.
2022-02-07
Pure EP - 5 x 10 pin Yoked Jumper Cable Green - 5 cables in one bag with 10 pin yoked jumper cables green to split ECG signals between two ECG devices is an accessory to the PURE EP System.The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit),and the personal computer (PC), which are connected over a highspeedfiber optic cable. The patient is connected to the amplifier viaa set of supplied ECG cables and commercially availableintracardiac (IC) catheters. The amplifier includes hardware andembedded software necessary for acquiring ECG and IC signalsfrom patients. The device is not intended for active patientmonitoring. It consists of one ECG and seven IC modules designedto acquire 12-lead ECG and 56 IC signals and send the digitizeddata to the PC. The PC has preinstalled PURE-EP software and isconnected to display monitors. The pre-installed software providesvisualization of received data from the amplifier on real-time andreview screens. It also includes a signal processing module thatprovides various filter options for real-time and review screens.
2022-02-07
Pure EP - 5 x 10 pin Yoked Jumper Cable Blue - 5 cables in one bag with 10 pin yoked jumper cables blue to split ECG signals between two ECG devices is an accessory to the PURE EP SystemThe PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit),and the personal computer (PC), which are connected over a highspeedfiber optic cable. The patient is connected to the amplifier viaa set of supplied ECG cables and commercially availableintracardiac (IC) catheters. The amplifier includes hardware andembedded software necessary for acquiring ECG and IC signalsfrom patients. The device is not intended for active patientmonitoring. It consists of one ECG and seven IC modules designedto acquire 12-lead ECG and 56 IC signals and send the digitizeddata to the PC. The PC has preinstalled PURE-EP software and isconnected to display monitors. The pre-installed software providesvisualization of received data from the amplifier on real-time andreview screens. It also includes a signal processing module thatprovides various filter options for real-time and review screens.
2022-02-07
Pure EP - 5 x 10 pin Yoked Jumper Cable White - 5 cables in one bag with 10 pin yoked jumper cables yellow to split ECG signals between two ECG devices is an accessory to the PURE EP System.The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit),and the personal computer (PC), which are connected over a highspeedfiber optic cable. The patient is connected to the amplifier viaa set of supplied ECG cables and commercially availableintracardiac (IC) catheters. The amplifier includes hardware andembedded software necessary for acquiring ECG and IC signalsfrom patients. The device is not intended for active patientmonitoring. It consists of one ECG and seven IC modules designedto acquire 12-lead ECG and 56 IC signals and send the digitizeddata to the PC. The PC has preinstalled PURE-EP software and isconnected to display monitors. The pre-installed software providesvisualization of received data from the amplifier on real-time andreview screens. It also includes a signal processing module thatprovides various filter options for real-time and review screens.
2022-02-07
Pure EP - 5 x Single Jumper Cable Black 0.1m - 5 cables in one bag with single jumper cables black to split ECG signals between two ECG devices is an accessory to the PURE EP System.The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit),and the personal computer (PC), which are connected over a highspeedfiber optic cable. The patient is connected to the amplifier viaa set of supplied ECG cables and commercially availableintracardiac (IC) catheters. The amplifier includes hardware andembedded software necessary for acquiring ECG and IC signalsfrom patients. The device is not intended for active patientmonitoring. It consists of one ECG and seven IC modules designedto acquire 12-lead ECG and 56 IC signals and send the digitizeddata to the PC. The PC has preinstalled PURE-EP software and isconnected to display monitors. The pre-installed software providesvisualization of received data from the amplifier on real-time andreview screens. It also includes a signal processing module thatprovides various filter options for real-time and review screens.
2022-02-07
Pure EP - 5 x Single Jumper Cable Black 0.3m - 5 cables in one bag with single jumper cables black to split ECG signals between two ECG devices is an accessory to the PURE EP System.The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit),and the personal computer (PC), which are connected over a highspeedfiber optic cable. The patient is connected to the amplifier viaa set of supplied ECG cables and commercially availableintracardiac (IC) catheters. The amplifier includes hardware andembedded software necessary for acquiring ECG and IC signalsfrom patients. The device is not intended for active patientmonitoring. It consists of one ECG and seven IC modules designedto acquire 12-lead ECG and 56 IC signals and send the digitizeddata to the PC. The PC has preinstalled PURE-EP software and isconnected to display monitors. The pre-installed software providesvisualization of received data from the amplifier on real-time andreview screens. It also includes a signal processing module thatprovides various filter options for real-time and review screens.
2022-02-07
Pure EP - 5 x Single Jumper Cable Red 0.3m - 5 cables in one bag with single jumper cables red to split ECG signals between two ECG devices is an accessory to the PURE EP SystemThe PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit),and the personal computer (PC), which are connected over a highspeedfiber optic cable. The patient is connected to the amplifier viaa set of supplied ECG cables and commercially availableintracardiac (IC) catheters. The amplifier includes hardware andembedded software necessary for acquiring ECG and IC signalsfrom patients. The device is not intended for active patientmonitoring. It consists of one ECG and seven IC modules designedto acquire 12-lead ECG and 56 IC signals and send the digitizeddata to the PC. The PC has preinstalled PURE-EP software and isconnected to display monitors. The pre-installed software providesvisualization of received data from the amplifier on real-time andreview screens. It also includes a signal processing module thatprovides various filter options for real-time and review screens.
2022-02-07
Pure EP - ECG Cable - The ECG Cable is an accessory to the PURE EP™ System. The ECG cable Assembly (4.8m) connects to standard ECG patches on the patient’s skin. The cable connects directly to the blue plug on the amplifier (aka MSU - Main System Unit).The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit),and the personal computer (PC), which are connected over a highspeedfiber optic cable. The patient is connected to the amplifier viaa set of supplied ECG cables and commercially availableintracardiac (IC) catheters. The amplifier includes hardware andembedded software necessary for acquiring ECG and IC signalsfrom patients. The device is not intended for active patientmonitoring. It consists of one ECG and seven IC modules designedto acquire 12-lead ECG and 56 IC signals and send the digitizeddata to the PC. The PC has preinstalled PURE-EP software and isconnected to display monitors. The pre-installed software providesvisualization of received data from the amplifier on real-time andreview screens. It also includes a signal processing module thatprovides various filter options for real-time and review screens.
2021-06-30
Pure EP - Catheter Input Module - The Catheter Input Module - IC2 J-Box Bipolar Cable Assembly (3m) is an accessory to the PURE EP™ System. The catheter input modules are used for connecting the IC catheters to the amplifier (aka MSU - Main System Unit).The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit),and the personal computer (PC), which are connected over a highspeedfiber optic cable. The patient is connected to the amplifier viaa set of supplied ECG cables and commercially availableintracardiac (IC) catheters. The amplifier includes hardware andembedded software necessary for acquiring ECG and IC signalsfrom patients. The device is not intended for active patientmonitoring. It consists of one ECG and seven IC modules designedto acquire 12-lead ECG and 56 IC signals and send the digitizeddata to the PC. The PC has preinstalled PURE-EP software and isconnected to display monitors. The pre-installed software providesvisualization of received data from the amplifier on real-time andreview screens. It also includes a signal processing module thatprovides various filter options for real-time and review screens.
2021-06-30
Pure EP - Catheter Input Module - The Catheter Input Module - IC1 J-Box Unipolar/Bipolar Cable Assembly (3m) is an accessory to the PURE EP™ System. The catheter input modules are used for connecting the IC catheters to the amplifier (aka MSU - Main System Unit).The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit),and the personal computer (PC), which are connected over a highspeedfiber optic cable. The patient is connected to the amplifier viaa set of supplied ECG cables and commercially availableintracardiac (IC) catheters. The amplifier includes hardware andembedded software necessary for acquiring ECG and IC signalsfrom patients. The device is not intended for active patientmonitoring. It consists of one ECG and seven IC modules designedto acquire 12-lead ECG and 56 IC signals and send the digitizeddata to the PC. The PC has preinstalled PURE-EP software and isconnected to display monitors. The pre-installed software providesvisualization of received data from the amplifier on real-time andreview screens. It also includes a signal processing module thatprovides various filter options for real-time and review screens.
2021-06-30
Pure EP - PURE EP™ is a system consists of two main parts: the amplifier (aka MSU - Main System Unit),and the personal computer (PC), which are connected over a highspeedfiber optic cable. The patient is connected to the amplifier viaa set of supplied ECG cables and commercially availableintracardiac (IC) catheters. The amplifier includes hardware andembedded software necessary for acquiring ECG and IC signalsfrom patients. The device is not intended for active patientmonitoring. It consists of one ECG and seven IC modules designedto acquire 12-lead ECG and 56 IC signals and send the digitizeddata to the PC. The PC has preinstalled PURE-EP software and isconnected to display monitors. The pre-installed software providesvisualization of received data from the amplifier on real-time andreview screens. It also includes a signal processing module thatprovides various filter options for real-time and review screens.
2021-05-05
Pure EP - Dual ECG Splitter Box - The Dual ECG Splitter Box is an accessory to the PURE EP™ System. It allows splitting a single array of input ECG signals into two output signals to use in conjunction with the PURE EP™ system.The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit),and the personal computer (PC), which are connected over a highspeedfiber optic cable. The patient is connected to the amplifier viaa set of supplied ECG cables and commercially availableintracardiac (IC) catheters. The amplifier includes hardware andembedded software necessary for acquiring ECG and IC signalsfrom patients. The device is not intended for active patientmonitoring. It consists of one ECG and seven IC modules designedto acquire 12-lead ECG and 56 IC signals and send the digitizeddata to the PC. The PC has preinstalled PURE-EP software and isconnected to display monitors. The pre-installed software providesvisualization of received data from the amplifier on real-time andreview screens. It also includes a signal processing module thatprovides various filter options for real-time and review screens.
2021-05-12