510(k) K974129 ยท ESD Hearing Aid, Air-Conduction, Prescription
HI-69E, HI-69N, HI-69P
| Applicant | Rockwin Corp., Dekalb IL, US |
| Decision | Substantially Equivalent, Dec 12, 1997 |
| Received | Nov 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974129
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.