FDA Registration
Active
🇺🇸 United States
Overa
Reg #: 3004869564
·
FEI: 3004869564
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Aspira Women's Health, Inc.
- Registration Number
- 3004869564
- FEI Number
- 3004869564
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 12117 FM2244 #3 suite 100
- City
- Austin
- State
- TX
- ZIP
- 78738
- Country
- US
Regulatory Submissions
- 510(k) Number
- K150588
Owner / Operator
- Firm Name
- Aspira Women's Health
- Operator Number
- 9077721
- Address
- 12117 FM2244 #3 suite 100
- City
- Austin
- State
- TX
- Postal Code
- 78738
- Country
- US
- Correspondent
- Silvana Franco
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ovarian Adnexal Mass Assessment Score Test System | ONX | Class 2 | Obstetrics/Gynecology | No | 2019-08-22 |
Proprietary Names
Overa
Establishment Types
Manufacture Medical Device