510(k) K860008 ยท ESD Hearing Aid, Air-Conduction, Prescription
AM 31, HEARING AID
| Applicant | Electone, Inc., Winter Park FL, US |
| Decision | Substantially Equivalent, Mar 12, 1986 |
| Received | Jan 3, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860008
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.