510(k) K864031 ยท ESD Hearing Aid, Air-Conduction, Prescription
MODEL AK 8184 CUSTOM-LOW-PROFILE HEARING AID
| Applicant | Int'L Hearing Aids, Inc., Hopkins MN, US |
| Decision | Substantially Equivalent, Nov 13, 1986 |
| Received | Oct 15, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864031
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.