Universal SmartECG
VectraCor, Inc.
VectraCor, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2133542 | 1000520092 | VectraCor, Inc. | 1 | N | 2026-01-01 | 6901 E. Fish Lake Road Suite 190 Maple Grove MN US 55369 |
| 3009443693 | 3009443693 | VectraCor, Inc. | 1 | N | 2026-01-01 | 785 Totowa Rd Suite 100 Totowa NJ US 07512 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 135441 | 1610000642 | K990266 | MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE | LOS | 1999-02-02 |
| 135441 | 1948505715 | K952969 | EIDOS 5003 HOLTER SYSTEM | DQK | 1996-07-16 |
| 135441 | 1179744486 | K173952 | Universal SmartECG | DPS | 2018-08-28 |
| 135441 | 1372510219 | K140852 | VECTRAPLEX CMS | MSX | 2015-01-30 |
| 135441 | 1090060329 | K120880 | ORBIT | BZG | 2012-04-19 |
| 135441 | 1717043733 | K102723 | MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS | MWJ | 2010-12-09 |
| 135441 | 1999312185 | K102378 | VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI | DPS | 2011-11-02 |
| 135441 | 1011904461 | K030073 | VERMED A10021 RESTING EKG TAB ELECTRODE | DRX | 2003-03-28 |
| 178718 | 1011904461 | K030073 | VERMED A10021 RESTING EKG TAB ELECTRODE | DRX | 2003-03-28 |
| 135441 | 1006016032 | ||||
| 178718 | 1463272398 | ||||
| 135441 | 1610371900 | ||||
| 178718 | 1610371900 | ||||
| 135441 | 1794117983 | ||||
| 178718 | 1794117983 |
Product Codes Associated With Registrations#
PMN#
VECTRAPLEX CMS
VECTRACOR, INC
VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI
VECTRACOR, INC
GUDID#
VectraplexECG System - VectraplexECG System with Cardio Electrical Bio-marker (CEB)
2016-09-26
Office Medic - Office Medic Software
2017-01-23
Plastic Mouthpieces (100) - Plastic Mouthpieces box of 100
2016-09-26
3L Calibration Syringe - The 3L calibration syringe is a hollow cylindrical tube with a nozzle at one end that connects to a VectraCor pneumotachometer, and a handle/plunger on the other end. As the handle is pulled back the tube fills with a known quantity of air. If the device is connected to a VectraCor spirometer device with a VectraCor pneumotachometer, as the handle is depressed air is pushed into the spirometer. This will allow users to check if the VectraCor spirometer device is within calibration values.
2023-06-07
Universal SmartECG - The Universal SmartECG is an ECG amplifier that connects to electrodes on a patient and a PC with Windows operating systems via a USB connection. The ECG amplifier detects electrical impulses from the patient and coverts them into a digital signal that can be displayed and recorded on the computer.The ECG system consists of a 12-lead ECG, multi-language Office Medic Software and VectraplexECG, a UL 60950 compliant host computer and accessories. The 12-lead ECG includes an analog front end designed to detect, amplify, filter, and output biopotential measurements in real time, a microprocessor to communicate and control the analog front end and system, short circuit protection, ESD protection, defibrillation isolation and protection, a green indication LED, 10 leadwires, lead off detection, USB communication to PC and Office Medic or VectraplexECG, and bootloader. The device is powered by the USB connector and is regulated to two separate supplies, a3.3V digital supply and a 3.3V analog supply to respectively power the digital and analog circuitry.The 12-lead ECG outputs ECG waveform information via USB to the Office Medic or VectraplexECG Software that translates, filters, analyzes, and displays the ECG waveform in real time. The hardware contains an FTDI USB UART translator chip to install required USB drivers to the PC and allow appropriate data conversion to the PC during ECG measurement.
2023-06-07
Universal ECG - ECG Amplifier
2016-09-24
Vectraplex CMS - Vectraplex Central Monitoring System
2016-09-26
Orbit Spirometer - Z-7000-0101
2016-09-24
Wet Gel Monitoring Electrodes - Wet Gel Electrodes Inner Pack of 5
2016-09-26
Adhesive Solid Gel Electrodes (pack of 100) - Resting EKG Tab Electrodes inner pack of 100
2016-09-26
Nose Clips - 724050-00
2016-09-26
Nose Clips - 7242005-00
2017-02-03
Holter Prep Kit - Holter prep kitEach prep kit contains:1 razor1 alcohol pad1 AA battery1 skin scrubby1 page of 5 wet gel electrodes1 patient diary
2016-09-26