K251381
- 510(k) number
- K251381
- Device name
- Ceribell Instant EEG Headcap (Small: C251, Medium: C252)
- Applicant
- Ceribell, Inc. CA · US
- Product code
- GXY — Electrode, Cutaneous
- Decision date
- 2025-10-31
- Date received
- 2025-05-02
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251381.pdf
Official FDA record: K251381
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.