K260363
- 510(k) number
- K260363
- Device name
- Ceribell Brain Monitor Headband
- Applicant
- Ceribell, Inc. CA · US
- Product code
- GXY — Electrode, Cutaneous
- Decision date
- 2026-04-03
- Date received
- 2026-02-04
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K260363.pdf
Official FDA record: K260363
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.