510(k) K240408 ยท OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
REMI-AI Rapid Detection Module (REMI-AI RDM)
| Applicant | Epitel, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Oct 17, 2024 |
| Received | Feb 9, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240408
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.