Cleared Traditional

Ceribell Instant EEG Headband

K171459 · Ceribell, Inc. · Neurology
Aug 2017
Decision
95d
Days
Class 2
Risk

About This 510(k) Submission

K171459 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 21, 2017, 95 days after receiving the submission on May 18, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K171459 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 2017
Decision Date August 21, 2017
Days to Decision 95 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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