510(k) K082035 ยท GWJ Stimulator, Auditory, Evoked Response
MAICO MB 11 WITH BERAPHONE PROBE
| Applicant | Maico Diagnostics, Minnesota MN, US |
| Decision | Substantially Equivalent, Jan 29, 2009 |
| Received | Jul 17, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082035
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.