510(k) K950319 ยท ESD Hearing Aid, Air-Conduction, Prescription
RESOUND(R) PERSONAL HEARING SYSTEM ED-3 ENCORE
| Applicant | Resound Corp., Redwood City CA, US |
| Decision | Substantially Equivalent, Feb 8, 1995 |
| Received | Jan 26, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950319
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.