Cleared Traditional

autoSCORE (V 2.0.0)

K243743 · Holberg Eeg AS · Neurology

Apr 2025

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K243743 is an FDA 510(k) clearance for the autoSCORE (V 2.0.0), 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 April 9, 2025, 126 days after receiving the submission on December 4, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K243743 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 04, 2024
Decision Date	April 09, 2025
Days to Decision	126 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