510(k) K935458 ยท ESD Hearing Aid, Air-Conduction, Prescription
AUDIPHON, MODEL H-11
| Applicant | National Hearing Aid Dist., Inc., Boston MA, US |
| Decision | Substantially Equivalent, Jan 5, 1994 |
| Received | Nov 12, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935458
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.