510(k) K063338 ยท EWO Audiometer
HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER
| Applicant | Mimosa Acoustics, Inc., Champaign IL, US |
| Decision | Substantially Equivalent, Jan 4, 2007 |
| Received | Nov 6, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063338
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.