FDA Registration
Active
🇺🇸 United States
ONYX HEALTHCARE USA, INC.
Reg #: 3010209365
·
FEI: 3010209365
·
Expires 2025
Products
4
Proprietary Names
0
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- ONYX HEALTHCARE USA, INC.
- Registration Number
- 3010209365
- FEI Number
- 3010209365
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 324 W Blueridge Ave
- City
- Orange
- State
- CA
- ZIP
- 92865
- Country
- US
Regulatory Submissions
- 510(k) Number
- K112718
Owner / Operator
- Firm Name
- ONYX Healthcare USA, Inc.
- Operator Number
- 10043939
- Address
- 324 West Blueridge Ave.
- City
- Orange
- State
- CA
- Postal Code
- 92865
- Country
- US
- Correspondent
- Brian Wang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2013-04-11 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2013-04-11 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2013-04-11 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2013-04-11 |
Establishment Types
Manufacture Medical Device