Device Classification Name |
air-conduction hearing aid software
|
De Novo Number |
DEN230081 |
Device Name |
Hearing Aid Feature (HAF) |
Requester |
apple inc. |
one apple park way |
cupertino,
CA
95014
|
|
Contact |
kevin go |
|
Regulation Number | 874.3335
|
Classification Product Code |
|
Date Received | 12/04/2023 |
Decision Date | 09/12/2024 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Ear Nose & Throat
|
Review Advisory Committee |
Ear Nose & Throat
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|