510(k) K964132 ยท EWO Audiometer
MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT
| Applicant | Bio-Logic Systems Corp., Mudelein IL, US |
| Decision | Substantially Equivalent, May 13, 1997 |
| Received | Oct 15, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964132
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.