K261101
- 510(k) number
- K261101
- Device name
- Ceribell Monitor
- Applicant
- Ceribell, Inc. CA · US
- Product code
- OMC — Reduced- Montage Standard Electroencephalograph
- Decision date
- 2026-06-30
- Date received
- 2026-04-02
- 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: K261101.pdf
Official FDA record: K261101
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.