K243185
- 510(k) number
- K243185
- Device name
- REMI Remote EEG Monitoring System
- Applicant
- Epitel UT · US
- Product code
- OMC — Reduced- Montage Standard Electroencephalograph
- Decision date
- 2025-03-21
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243185.pdf
Official FDA record: K243185
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.