Ceribell Brain Monitor Headband— 510(k) K260363
Substantially EquivalentCeribell, Inc.
FDA 510(k) clearance K260363 for Ceribell Brain Monitor Headband, Substantially Equivalent on 2026-04-03. Applicant: Ceribell, Inc.. Device class: 2.
Summary
Ceribell's Ceribell Brain Monitor Headband is filed under product code GXY (Electrode, Cutaneous).
Class II, 21 CFR 882.1320. It came in as an Abbreviated 510(k), and Neurology is both the classification panel and the review panel.
Ceribell filed from Sunnyvale, California. Review took 58 calendar days (February 4 to April 3, 2026).
Clearance details
- Applicant
- Ceribell, Inc.
- Product code
- Product code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Sunnyvale, CA, US
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More clearances from Ceribell, Inc.
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