510(k) K961447 ยท EWO Audiometer
SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE) TEST INSTRUMENT
| Applicant | Bio-Logic Systems Corp., Mudelein IL, US |
| Decision | Substantially Equivalent, May 29, 1996 |
| Received | Apr 16, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961447
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.