510(k) K971535 ยท ESD Hearing Aid, Air-Conduction, Prescription
WIDEX SENSO DIGITAL (MINI CANAL)
| Applicant | Widex Hearing Aid Co., Inc., Long Island City NY, US |
| Decision | Substantially Equivalent, Jun 6, 1997 |
| Received | Apr 28, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971535
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.