Cleared Traditional

Ceribell Instant EEG Headband

K210805 · Ceribell, Inc. · Neurology
Aug 2021
Decision
166d
Days
Class 2
Risk

About This 510(k) Submission

K210805 is an FDA 510(k) clearance for the Ceribell Instant EEG Headband, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Ceribell, Inc. (Mountainview, US). The FDA issued a Cleared decision on August 30, 2021, 166 days after receiving the submission on March 17, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K210805 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2021
Decision Date August 30, 2021
Days to Decision 166 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXY — Electrode, Cutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1320

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