510(k) K915450 ยท ESD Hearing Aid, Air-Conduction, Prescription
IN THE EAR HEARING AID
| Applicant | Zenith/Omni Hearing Instruments, Inc., New Haven CT, US |
| Decision | Substantially Equivalent, Feb 27, 1992 |
| Received | Dec 5, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915450
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.