510(k) K954038 ยท ESD Hearing Aid, Air-Conduction, Prescription
K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENT
| Applicant | Argosy Electronics, Eden Prairie MN, US |
| Decision | Substantially Equivalent, Sep 18, 1995 |
| Received | Aug 28, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954038
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.