Cleared Traditional

Ceribell Status Epilepticus Monitor

K223504 · Ceribell, Inc. · Neurology

May 2023

Decision

182d

Days

Class 2

Risk

About This 510(k) Submission

K223504 is an FDA 510(k) clearance for the Ceribell Status Epilepticus Monitor, a Automatic Event Detection Software For Full-montage Electroencephalograph (Class II — Special Controls, product code OMB), submitted by Ceribell, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on May 23, 2023, 182 days after receiving the submission on November 22, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K223504 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 22, 2022
Decision Date	May 23, 2023
Days to Decision	182 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