510(k) K011746 ยท GWJ Stimulator, Auditory, Evoked Response
MB 11
| Applicant | Maico Diagnostic GmbH, Eden Prairie MN, US |
| Decision | Substantially Equivalent, Aug 24, 2001 |
| Received | Jun 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011746
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.