510(k) K936007 ยท ESD Hearing Aid, Air-Conduction, Prescription
PRIZM HEARING SYSTEM, MODEL POWER BTE
| Applicant | Audioscience, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Mar 4, 1994 |
| Received | Dec 16, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K936007
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.