K231779
- 510(k) number
- K231779
- Device name
- REMI AI Discrete Detection Module
- Applicant
- Epitel, Inc. UT · US
- Product code
- OMB — Automatic Event Detection Software For Full-Montage
- Decision date
- 2024-01-03
- Date received
- 2023-06-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K231779.pdf
Official FDA record: K231779
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.