Cleared Traditional

autoSCORE

K231068 · Holberg Eeg AS · Neurology

Jan 2024

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K231068 is an FDA 510(k) clearance for the autoSCORE, a Automatic Event Detection Software For Full-montage Electroencephalograph (Class II — Special Controls, product code OMB), submitted by Holberg Eeg AS (Bergen, NO). The FDA issued a Cleared decision on January 7, 2024, 268 days after receiving the submission on April 14, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K231068 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 14, 2023
Decision Date	January 07, 2024
Days to Decision	268 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