Autoscore

Basic Information

• Brand Name: Autoscore
• Primary DI: 05060941990018
• Version / Model: AS001 V2
• Catalog Number: AS001 V2
• Company Name: Holberg Eeg AS
• Labeler DUNS: 671267551
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-28
• Public Version: 1
• Public Version Date: 2026-02-05
• Public Version Status: New
• Public Device Record Key: a4b624cb-a863-41e7-87a0-def18461783f

Device Description

Autoscore

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OMB	Automatic Event Detection Software For Full-Montage Electroencephalograph	Neurology	882.1400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
67670	Electroencephalographic diagnosis-support software	A software program intended to acquire and process neurological physiological parameter data [primarily electroencephalographic (EEG)] to assist a healthcare professional in the diagnosis of neurological conditions. It has a general-purpose neurological use and is not dedicated to, e.g., sleep monitoring, psychiatric analysis, or seizure-detection.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060941990018	GS1

Premarket Submissions

Submission Number	Supplement Number
K243743	000