510(k) K963788 ยท ESD Hearing Aid, Air-Conduction, Prescription
PRIMOFOCUS COMPACT
| Applicant | Oticon Corp., Somerset NJ, US |
| Decision | Substantially Equivalent, Nov 27, 1996 |
| Received | Sep 20, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963788
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.