BHA100 Series Braun Clear Hearing Aid— 510(k) K212609
Substantially EquivalentKaz USA, Inc., A Helen of Troy Company
FDA 510(k) clearance K212609 for BHA100 Series Braun Clear Hearing Aid, Substantially Equivalent on 2022-01-05. Applicant: Kaz USA, Inc., A Helen of Troy Company. Device class: 2.
Clearance details
- Applicant
- Kaz USA, Inc., A Helen of Troy Company
- Product code
- Code QDD
- Device class
- Class 2
- Regulation
- 21 CFR 874.3325
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlborough, MA, US
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