510(k) K963745 ยท ESD Hearing Aid, Air-Conduction, Prescription
MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR)
| Applicant | Hearing Innovations, Inc., Tucson AZ, US |
| Decision | Substantially Equivalent, Nov 26, 1996 |
| Received | Sep 17, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963745
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.