510(k) K212609 ยท QDD Self-Fitting Air-Conduction Hearing Aid, Prescription
BHA100 Series Braun Clear Hearing Aid
| Applicant | Kaz USA, Inc., A Helen of Troy Company, Marlborough MA, US |
| Decision | Substantially Equivalent, Jan 5, 2022 |
| Received | Aug 17, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212609
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.