510(k) K864180 ยท ESD Hearing Aid, Air-Conduction, Prescription
INTEGRA, CUSTOM IN-THE-EAR HEARING AID
| Applicant | Bernafon, Inc., Mountainside NJ, US |
| Decision | Substantially Equivalent, Nov 5, 1986 |
| Received | Oct 27, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864180
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.