DEN230081
- 510(k) number
- DEN230081
- Device name
- Hearing Aid Feature (HAF)
- Applicant
- Apple, Inc. CA · US
- Product code
- SCR — Air-Conduction Hearing Aid Software
- Decision date
- 2024-09-12
- Date received
- 2023-12-04
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Ear, Nose, Throat
Official FDA record: DEN230081
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.