Cleared Special

Ceribell Instant EEG Headband

K232052 · Ceribell, Inc. · Neurology
Aug 2023
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K232052 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. (Sunnyvale, US). The FDA issued a Cleared decision on August 8, 2023, 29 days after receiving the submission on July 10, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K232052 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 2023
Decision Date August 08, 2023
Days to Decision 29 days
Submission Type Special
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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