510(k) K953960 ยท ESD Hearing Aid, Air-Conduction, Prescription
HEARING AID (ALL-IN-THE-EAR)
| Applicant | Audina Hearing Instrument, Longwood FL, US |
| Decision | Substantially Equivalent, Sep 12, 1995 |
| Received | Aug 22, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953960
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.