Cleared Abbreviated

Ceribell Instant EEG Headcap

K223086 · Ceribell, Inc. · Neurology
Mar 2023
Decision
173d
Days
Class 2
Risk

About This 510(k) Submission

K223086 is an FDA 510(k) clearance for the Ceribell Instant EEG Headcap, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Ceribell, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on March 22, 2023, 173 days after receiving the submission on September 30, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K223086 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2022
Decision Date March 22, 2023
Days to Decision 173 days
Submission Type Abbreviated
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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