Device Classification Name |
Self-Fitting Air-Conduction Hearing Aid, Prescription
|
510(k) Number |
K212609 |
Device Name |
BHA100 Series Braun Clear Hearing Aid |
Applicant |
Kaz USA, Inc., a Helen of Troy Company |
400 Donald Lynch Boulevard, Suite 300 |
Marlborough,
MA
01752
|
|
Applicant Contact |
Matt J. Baun |
Correspondent |
Kaz USA, Inc., a Helen of Troy Company |
400 Donald Lynch Boulevard, Suite 300 |
Marlborough,
MA
01752
|
|
Correspondent Contact |
Matt J. Baun |
Regulation Number | 874.3325
|
Classification Product Code |
|
Date Received | 08/17/2021 |
Decision Date | 01/05/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|