Devices · Holberg EEG AS

autoSCORE (V 2.0.0)

Holberg EEG AS is listed for autoSCORE (V 2.0.0) (K243743). The FDA list gives April 9, 2025 as the date of the final decision. The lead panel is Neurology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code OMB as “Automatic Event Detection Software For Full-Montage Electroencephalograph”: 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 openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243743

Official FDA database record

Date of final decision

April 9, 2025

Company on the FDA list

Holberg EEG AS

Lead panel

Neurology

Primary product code

OMB

openFDA device name for the code

Automatic Event Detection Software For Full-Montage Electroencephalograph

Device class

2

Regulation number

882.1400

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary