510(k) K944359 ยท ESD Hearing Aid, Air-Conduction, Prescription
EXPRESSION RX-12, ENHANCEMENT RX-34, ELITE RX-12
| Applicant | Rexton, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Dec 29, 1994 |
| Received | Sep 7, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944359
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.