FDA Registration
Active
🇺🇸 United States
VitalConnect, Inc.
Reg #: 3022123357
·
FEI: 3010830833
·
Expires 2026
Products
4
Proprietary Names
3
Establishment Types
4
Classifications
4
Registration Details
- Registration Name
- VitalConnect, Inc.
- Registration Number
- 3022123357
- FEI Number
- 3010830833
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2870 Zanker Road, Suite 100
- City
- San Jose
- State
- CA
- ZIP
- 95134
- Country
- US
Regulatory Submissions
- 510(k) Number
- K192757
Owner / Operator
- Firm Name
- VitalConnect, Inc.
- Operator Number
- 10046585
- Address
- 2870 Zanker Road, Suite 100
- City
- San Jose
- State
- CA
- Postal Code
- 95134
- Country
- US
- Correspondent
- Edward J Sinclair
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2019-03-11 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2020-09-23 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2020-09-23 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2020-09-23 |
Proprietary Names
VitalConnect Platform, VitalPatch Adhesive Overlay
VitalPatch
VistaSolution
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Reprocess Single-Use Device
Repack or Relabel Medical Device