510(k) K954516 ยท ESD Hearing Aid, Air-Conduction, Prescription
UNITRON MODEL SOUND F/X II
| Applicant | Unitron Industries, Inc., Port Huron MI, US |
| Decision | Substantially Equivalent, Oct 7, 1995 |
| Received | Sep 28, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954516
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.