FDA Registration Active 🇺🇸 United States

VectraCor, Inc.

Reg #: 3009443693 · FEI: 3009443693 · Expires 2026
Products
12
Proprietary Names
21
Establishment Types
4
Classifications
11

Registration Details

Registration Name
VectraCor, Inc.
Registration Number
3009443693
FEI Number
3009443693
Status
Active
Expiry Year
2026
Initial Importer
No
Address
785 Totowa Rd Suite 100
City
Totowa
State
NJ
ZIP
07512
Country
US

Regulatory Submissions

510(k) Number
K952969

Owner / Operator

Firm Name
VectraCor, Inc.
Operator Number
10038931
Address
785 Totowa Rod, Suite 100
City
Totowa
State
NJ
Postal Code
07512
Country
US
Correspondent
Brad S Schreck

Products

Device Name Product Code
Computer, Diagnostic, Programmable DQK
Clip, Nose BXJ
Shave Prep Kit OJW
Electrocardiograph DPS
Monitor, St Segment With Alarm MLD
LOS
Electrocardiograph, Ambulatory (Without Analysis) MWJ
Electrode, Electrocardiograph DRX
System, Network And Communication, Physiological Monitors MSX
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
Spirometer, Diagnostic BZG
Calibrator, Volume, Gas BXW

Proprietary Names

V300 Platnium VectraCor Platinum Trillium Platinum Vet Eidos 5003 V300 Silver V300 Platinum Vet VectraCor Platinum Vet VectraCor Silver V300 Gold VectraCor Gold Nose Clips Holter Prep Kit Universal SmartECG VectraplexECG System with VectraplexAMI V300 Holter Recorder V300 Holter Monitor Electrode Vectraplex CMS Orbit Spirometer Universal ECG 3L Calibration Syringe

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device