510(k) K954922 ยท ESD Hearing Aid, Air-Conduction, Prescription
REXTON'S HORIZION FAMILY OF MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMBALE INSTRUMENTS
| Applicant | Rexton, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Jan 17, 1996 |
| Received | Oct 26, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954922
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.