Device Classification Name |
Self-Fitting Air-Conduction Hearing Aid, Prescription
|
510(k) Number |
K211008 |
Device Name |
Bose SoundControl Hearing Aids |
Applicant |
Bose Corporation |
The Mountain Rd. |
Framingham,
MA
01701
|
|
Applicant Contact |
Bryn Kieras |
Correspondent |
Bose Corporation |
The Mountain Rd. |
Framingham,
MA
01701
|
|
Correspondent Contact |
Bryn Kieras |
Regulation Number | 874.3325
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/05/2021 |
Decision Date | 05/05/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|