510(k) K942107 ยท ESD Hearing Aid, Air-Conduction, Prescription
MAGIC EAR, ELAIN
| Applicant | Novaplex, Inc., Sun Valley CA, US |
| Decision | Substantially Equivalent, Feb 8, 1995 |
| Received | May 2, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942107
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.