FDA Registration
Active
🇺🇸 United States
T.Ox Tissue Oximeter
Reg #: 3003965364
·
FEI: 3003965364
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- VIOPTIX, INC.
- Registration Number
- 3003965364
- FEI Number
- 3003965364
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 39655 Eureka Dr
- City
- Newark
- State
- CA
- ZIP
- 94560
- Country
- US
Regulatory Submissions
- 510(k) Number
- K042657
Owner / Operator
- Firm Name
- VIOPTIX, INC.
- Operator Number
- 9051676
- Address
- 39655 Eureka Drive, --
- City
- Newark
- State
- CA
- Postal Code
- 94560
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter, Tissue Saturation | MUD | Class 2 | Cardiovascular | No | 2007-10-31 |
Proprietary Names
T.Ox Tissue Oximeter
ODISsey Tissue Oximeter
Establishment Types
Manufacture Medical Device