510(k) K193033 ยท GWJ Stimulator, Auditory, Evoked Response
GSI Audera Pro
| Applicant | Grason Stadler, Eden Prairie MN, US |
| Decision | Substantially Equivalent, Apr 24, 2020 |
| Received | Oct 31, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193033
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.