510(k) K964816 ยท ESD Hearing Aid, Air-Conduction, Prescription
AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR
| Applicant | Audina Hearing Instrument, Longwood FL, US |
| Decision | Substantially Equivalent, Jan 17, 1997 |
| Received | Nov 29, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964816
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.