510(k) K946045 ยท ESD Hearing Aid, Air-Conduction, Prescription
OTICON
| Applicant | Oticon, Inc., Somerset NJ, US |
| Decision | Substantially Equivalent, Jan 30, 1995 |
| Received | Dec 12, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946045
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.