510(k) K090579 ยท GWJ Stimulator, Auditory, Evoked Response
SMARTSCREENER-PLUS2
| Applicant | Intelligent Hearing Systems, Miami FL, US |
| Decision | Substantially Equivalent, Jul 7, 2009 |
| Received | Mar 3, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090579
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.