Ceribell Brain Monitor Headband— 510(k) K260363

Substantially Equivalent

Ceribell, Inc.

FDA 510(k) clearance K260363 for Ceribell Brain Monitor Headband, Substantially Equivalent on 2026-04-03. Applicant: Ceribell, Inc..

Clearance details

Applicant: Ceribell, Inc.
Product code: Code GXY
Advisory panel: Neurology
Date received: 2026-02-04
Decision date: 2026-04-03
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Sunnyvale, CA, US

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