510(k) K970880 ยท ESD Hearing Aid, Air-Conduction, Prescription
POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN
| Applicant | Micro-Ear Technology, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Jun 6, 1997 |
| Received | Mar 10, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970880
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.