FDA.reportPublic FDA data

VectraCor, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21335421000520092VectraCor, Inc.1N2026-01-016901 E. Fish Lake Road Suite 190 Maple Grove MN US 55369
30094436933009443693VectraCor, Inc.1N2026-01-01785 Totowa Rd Suite 100 Totowa NJ US 07512

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1354411610000642K990266MICROMEDICAL 12 LEAD SIMULTANEOUS CABLELOS1999-02-02
1354411948505715K952969EIDOS 5003 HOLTER SYSTEMDQK1996-07-16
1354411179744486K173952Universal SmartECGDPS2018-08-28
1354411372510219K140852VECTRAPLEX CMSMSX2015-01-30
1354411090060329K120880ORBITBZG2012-04-19
1354411717043733K102723MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSISMWJ2010-12-09
1354411999312185K102378VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMIDPS2011-11-02
1354411011904461K030073VERMED A10021 RESTING EKG TAB ELECTRODEDRX2003-03-28
1787181011904461K030073VERMED A10021 RESTING EKG TAB ELECTRODEDRX2003-03-28
1354411006016032
1787181463272398
1354411610371900
1787181610371900
1354411794117983
1787181794117983

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DPS22018-08-28
DRX22003-03-28
MSX12015-01-30
BZG12012-04-19
MWJ12010-12-09
LOS11999-02-02
DQK11996-07-16

PMN#

GUDID#

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.

VECTRACOR INC

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.

VECTRACOR INC

2023-06-07