510(k) K970537 ยท ESD Hearing Aid, Air-Conduction, Prescription
REXTON MODEL 48 AND 49PP
| Applicant | Rexton, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Mar 28, 1997 |
| Received | Feb 12, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970537
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.