510(k) K961827 ยท ESD Hearing Aid, Air-Conduction, Prescription
IN-THE-EAR
| Applicant | Qualitone, Minneapolis MN, US |
| Decision | Substantially Equivalent, Jul 3, 1996 |
| Received | May 13, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961827
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.