510(k) K122067 ยท GWJ Stimulator, Auditory, Evoked Response
TYPE 1077 ACCUSCREEN
| Applicant | Gn Otometrics, Taastrup, DK |
| Decision | Substantially Equivalent, Sep 27, 2012 |
| Received | Jul 16, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122067
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.