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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2024-12-19 |
| Clip, Nose | BXJ | Class 1 | Anesthesiology | No | 2016-09-06 |
| Shave Prep Kit | OJW | Class 2 | General, Plastic Surgery | No | 2016-08-22 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2018-08-31 |
| Monitor, St Segment With Alarm | MLD | Class 2 | Cardiovascular | No | 2018-08-31 |
| LOS | No | 2011-11-25 | |||
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | Class 2 | Cardiovascular | No | 2024-12-19 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2016-09-06 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2016-09-06 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2016-09-06 |
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2015-12-22 |
| Calibrator, Volume, Gas | BXW | Class 1 | Anesthesiology | No | 2016-09-06 |
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