510(k) K963878 ยท ESD Hearing Aid, Air-Conduction, Prescription
AHS OMEGA HF
| Applicant | Authorized Hearing Systems, Inc., Bristol PA, US |
| Decision | Substantially Equivalent, Dec 6, 1996 |
| Received | Sep 26, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963878
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.