510(k) K961308 ยท ESD Hearing Aid, Air-Conduction, Prescription
AUDIO 'D' INTIMA CIC
| Applicant | Hearing Solutions, Inc., Paoli PA, US |
| Decision | Substantially Equivalent, May 7, 1996 |
| Received | Apr 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961308
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.