510(k) K132957 ยท GWJ Stimulator, Auditory, Evoked Response
MADSEN ACCUSCREEN TYPE 1077
| Applicant | Gn Otometrics, Naples FL, US |
| Decision | Substantially Equivalent, Feb 27, 2014 |
| Received | Sep 20, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132957
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.