510(k) K972543 ยท ESD Hearing Aid, Air-Conduction, Prescription
TWIST PPAGC-1, TWIST PP
| Applicant | Trutone, Tulsa OK, US |
| Decision | Substantially Equivalent, Jul 23, 1997 |
| Received | Jul 9, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972543
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.