510(k) K935289 ยท ESD Hearing Aid, Air-Conduction, Prescription
PRO FIT-CYBER II OPTION
| Applicant | Qualitone, Minneapolis MN, US |
| Decision | Substantially Equivalent, Dec 22, 1993 |
| Received | Nov 3, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935289
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.