510(k) K031051 ยท GWJ Stimulator, Auditory, Evoked Response
SMARTEP-ASSR, MODEL M811007
| Applicant | Intelligent Hearing Systems, Miami FL, US |
| Decision | Substantially Equivalent, Feb 20, 2004 |
| Received | Apr 2, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031051
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.