Cleared Traditional

Ceribell Pocket EEG Device

K191301 · Ceribell, Inc. · Neurology

Sep 2019

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K191301 is an FDA 510(k) clearance for the Ceribell Pocket EEG Device, a Automatic Event Detection Software For Full-montage Electroencephalograph (Class II — Special Controls, product code OMB), submitted by Ceribell, Inc. (Mountainview, US). The FDA issued a Cleared decision on September 11, 2019, 120 days after receiving the submission on May 14, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K191301 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 14, 2019
Decision Date	September 11, 2019
Days to Decision	120 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OMB — Automatic Event Detection Software For Full-montage Electroencephalograph
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Automatically Mark Or Identify Electroencephalograph Waveforms For Spikes, Electrographic Seizures, Seizure-like Events In Order To Aid In Identification Of Such Events And Help Review And Annotation Of Prolonged Eeg Traces; All Output Subject To Verification By Qualified User