510(k) K254033— Ceribell Instant EEG Headset

Substantially Equivalent

Ceribell, Inc.

Clearance details

Applicant: Ceribell, Inc.
Product code: Code GXY
Advisory panel: Neurology
Date received: 2025-12-16
Decision date: 2026-02-09
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Sunnyvale, CA, US

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