510(k) DEN230081
- Device
- Hearing Aid Feature (HAF)
- Applicant
- Apple, Inc.
- 510(k) number
- DEN230081
- Product code
- SCR
- Decision
- Unknown (DENG)
- Decision date
- 2024-09-12
- Date received
- 2023-12-04
- Regulation
- 874.3335
- Classification name
- Air-Conduction Hearing Aid Software
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Kevin Go
- Address
- One Apple Park Way Cupertino CA US 95014 95014
FDA Registration Numbers#
- 3014343954
- 9617804
- 3023339161
- 3011016506
Source Documents#
510(k) summary PDF not indicated by FDA