510(k) K904926 ยท GWJ Stimulator, Auditory, Evoked Response
SMART-EP
| Applicant | Intelligent Hearing Systems, North Miami FL, US |
| Decision | Substantially Equivalent, Aug 2, 1991 |
| Received | Oct 31, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904926
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.