510(k) K961059 ยท ESD Hearing Aid, Air-Conduction, Prescription
DIGIFOCUS COMPACT
| Applicant | Oticon, Inc., Somerset NJ, US |
| Decision | Substantially Equivalent, May 7, 1996 |
| Received | Mar 18, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961059
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.