510(k) K925648 ยท GWJ Stimulator, Auditory, Evoked Response
SMART-SCREENER (AUDITORY)
| Applicant | Intelligent Hearing Systems, North Miami FL, US |
| Decision | Substantially Equivalent, May 11, 1993 |
| Received | Nov 9, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925648
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.