510(k) K964657 ยท ESD Hearing Aid, Air-Conduction, Prescription
SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF
| Applicant | Micro-Ear Technology, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Feb 11, 1997 |
| Received | Nov 20, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964657
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.