510(k) K111618 ยท EWO Audiometer
AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION
| Applicant | Natus Medical Incorporated, San Francisco CA, US |
| Decision | Substantially Equivalent, Dec 28, 2011 |
| Received | Jun 10, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111618
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.