FDA Registration
Active
🇺🇸 United States
Checkme O2/SpO2oxiband sleepmonitor
Reg #: 3011651103
·
FEI: 3011651103
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- VIVALNK, INC.
- Registration Number
- 3011651103
- FEI Number
- 3011651103
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 51 EAST CAMPBELL AVE., SUITE 160
- City
- Campbell
- State
- CA
- ZIP
- 95008
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191088
Owner / Operator
- Firm Name
- VivaLnk Inc
- Operator Number
- 10049171
- Address
- 51 EAST CAMPBELL AVE., SUITE 160
- City
- Campbell
- State
- CA
- Postal Code
- 95008
- Country
- US
- Correspondent
- quoi v huynh
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2022-01-04 |
Proprietary Names
Checkme O2/SpO2oxiband sleepmonitor
Establishment Types
Repack or Relabel Medical Device