Device Classification Name |
self-fitting air-conduction hearing aid, prescription
|
De Novo Number |
DEN180026 |
Device Name |
Bose Hearing Aid |
Requester |
bose corporation |
the mountain |
framingham,
MA
01701
|
|
Contact |
james yeagle |
|
Regulation Number | 874.3325
|
Classification Product Code |
|
Date Received | 05/11/2018 |
Decision Date | 10/05/2018 |
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
|
|
|