EWO
- Product code
- EWO
- Device name
- Audiometer
- Device class
- Class 2
- 21 CFR
- 21 CFR 874.1050
- Medical specialty
- Ear, Nose, Throat
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (last 3 years)
- 235
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K234095 | 2024-06-21 | Otodynamics | OtoNova/OtoNova Pro | |
| K240430 | 2024-03-15 | Otodynamics, Ltd. | Otoport Pro | |
| K231545 | 2023-10-27 | Hearx SA (Pty) , Ltd. | hearOAE |
Official FDA classification page: EWO
Classification and pathway per current FDA publications. Data from openFDA (CC0).