Ceribell Neurology Review Software— 510(k) K260998

Name: FDA 510(k) clearance K260998
Creator: U.S. Food and Drug Administration
Published: 2026-06-24

Substantially Equivalent

Ceribell, Inc.

FDA 510(k) clearance K260998 for Ceribell Neurology Review Software, Substantially Equivalent on 2026-06-24. Applicant: Ceribell, Inc.. Device class: 2.

Clearance details

Applicant: Ceribell, Inc.
Product code: Code OMB
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2026-03-26
Decision date: 2026-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.