510(k) K963047 ยท ESD Hearing Aid, Air-Conduction, Prescription
AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY)
| Applicant | Fenwick Hearing Instruments, Portland OR, US |
| Decision | Substantially Equivalent, Sep 10, 1996 |
| Received | Jul 29, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963047
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.