510(k) K231779 ยท OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
REMI AI Discrete Detection Module
| Applicant | Epitel, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Jan 3, 2024 |
| Received | Jun 16, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231779
No recall in the FDA data names this 510(k).
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