Ceribell Pocket EEG Device— 510(k) K191301

Substantially Equivalent

Ceribell, Inc.

FDA 510(k) clearance K191301 for Ceribell Pocket EEG Device, Substantially Equivalent on 2019-09-11. 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: 2019-05-14
Decision date: 2019-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountainview, 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.