510(k) K964898 ยท ESD Hearing Aid, Air-Conduction, Prescription
IN THE EAR HEARING AID
| Applicant | Keytone Hearing Laboratory, Little Rock AR, US |
| Decision | Substantially Equivalent, Apr 21, 1997 |
| Received | Dec 6, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964898
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.