510(k) K973885 ยท ESD Hearing Aid, Air-Conduction, Prescription
OTICON DIGISOUND ITE
| Applicant | Oticon, Inc., Somerset NJ, US |
| Decision | Substantially Equivalent, Nov 4, 1997 |
| Received | Oct 14, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973885
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.