K240408
- 510(k) number
- K240408
- Device name
- REMI-AI Rapid Detection Module (REMI-AI RDM)
- Applicant
- Epitel, Inc. UT · US
- Product code
- OMB — Automatic Event Detection Software For Full-Montage
- Decision date
- 2024-10-17
- Date received
- 2024-02-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K240408.pdf
Official FDA record: K240408
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.