510(k) K943808 ยท ESD Hearing Aid, Air-Conduction, Prescription
RIONET HM-02
| Applicant | Rockwin Corp., Dekalb IL, US |
| Decision | Substantially Equivalent, May 24, 1995 |
| Received | Aug 4, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943808
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.