K254033
- 510(k) number
- K254033
- Device name
- Ceribell Instant EEG Headset
- Applicant
- Ceribell, Inc. CA · US
- Product code
- GXY — Electrode, Cutaneous
- Decision date
- 2026-02-09
- Date received
- 2025-12-16
- 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: K254033.pdf
Official FDA record: K254033
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.