Ceribell Instant EEG Headset— 510(k) K254033
Substantially EquivalentCeribell, Inc.
FDA 510(k) clearance K254033 for Ceribell Instant EEG Headset, Substantially Equivalent on 2026-02-09. Applicant: Ceribell, Inc.. Device class: 2.
Summary
Ceribell's Ceribell Instant EEG Headset is filed under product code GXY, cutaneous electrode. The record doesn't describe the headset beyond its name and that code name.
Class II, 21 CFR 882.1320. Neurology is both the classification panel and the review panel, and it came in as an Abbreviated 510(k).
Ceribell filed from Sunnyvale, California. The substantially equivalent decision came 55 calendar days after receipt (December 16, 2025 to February 9, 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.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.