510(k) K960284 ยท ESD Hearing Aid, Air-Conduction, Prescription
OTICON /PRIMOFOCUS (PF)
| Applicant | Oticon, Inc., Somerset NJ, US |
| Decision | Substantially Equivalent, Mar 7, 1996 |
| Received | Jan 19, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960284
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.