Pure EP AE-0001-412

GUDID 08567500070008

PURE EP™ is a system consists of two main parts: the amplifier, and the personal computer (PC), which are connected over a highspeed fiber optic cable. The patient is connected to the amplifier via a set of supplied ECG cables and commercially available intracardiac (IC) catheters. The amplifier includes hardware and embedded software necessary for acquiring ECG and IC signals from patients. The device is not intended for active patient monitoring. It consists of one ECG and seven IC modules designed to acquire 12-lead ECG and 56 IC signals and send the digitized data to the PC. The PC has preinstalled PURE-EP software and is connected to display monitors. The pre-installed software provides visualization of received data from the amplifier on real-time and review screens. It also includes a signal processing module that provides various filter options for real-time and review screens.

BIOSIG TECHNOLOGIES, INC.

Cardiac electrophysiology analysis system

• Primary Device ID: 08567500070008
• NIH Device Record Key: 1b753f19-b8e7-40ce-a90b-d4ba308a53b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pure EP
• Version Model Number: AE-0001-412
• Catalog Number: AE-0001-412
• Company DUNS: 080048456
• Company Name: BIOSIG TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com
• Phone: 1-203-409-5444
• Email: eriechert@biosigtech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08567500070008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180805

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-28
• Device Publish Date: 2021-01-20

On-Brand Devices [Pure EP]

• 08567500070008: PURE EP™ is a system consists of two main parts: the amplifier, and the personal computer (PC)
• 00856750007000: PURE EP™ is a system consists of two main parts: the amplifier, and the personal computer (PC)