510(k) K861939 ยท ESD Hearing Aid, Air-Conduction, Prescription
MODEL PC HEARING AID
| Applicant | Fine-Tune, Deltona FL, US |
| Decision | Substantially Equivalent, Jun 23, 1986 |
| Received | May 20, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861939
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.