510(k) K971605 ยท ESD Hearing Aid, Air-Conduction, Prescription
RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION
| Applicant | Resound Corp., Redwood City CA, US |
| Decision | Substantially Equivalent, Jul 3, 1997 |
| Received | May 1, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971605
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.