FDA.reportPublic FDA data

Autoscore

Primary DI
05060941990018
Brand
Autoscore
Company
Holberg Eeg AS
Model
AS001 V2
Catalog number
AS001 V2
Device description
Autoscore
Published
2026-01-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMBAutomatic Event Detection Software For Full-Montage ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243743000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243743000autoSCORE (V 2.0.0)Holberg Eeg AS2025-04-09OMB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060941990018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060941990018050609419900185060941990018

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic diagnosis-support softwareA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
671267551
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850056774017NeuroMatchLVIS CORPORATIONOMB2026-05-12
09120109830269encevisAIT Austrian Institute of Technology GmbHOMB2025-08-05
00850056774000NeuroMatchLVIS CORPORATIONOMB2025-04-04
00860005388189REMI VigilenzEpitel, Inc.OMB2024-03-11
00869732000166Persyst 15 EEG Review and Analysis SoftwarePersyst Development CorpOMB2023-07-24
09120109830122encevisAIT Austrian Institute of Technology GmbHOMB2022-07-15
00382830058506NatusXLTEKOMB2021-10-07
00382830007443NatusXLTEKOMB2021-10-07
00851420007052Pocket EEG DeviceCERIBELL, INC.OMB2021-08-02
00382830058209NatusXLTEKOMB2021-04-20
00382830058216NatusXLTEKOMB2021-04-20
00382830058575NatusXLTEKOMB2021-04-20
09120109830078encevisAIT Austrian Institute of Technology GmbHOMB2021-01-11
00382830008020NatusXLTEKOMB2019-11-27
00382830010924NatusXLTEKOMB2019-11-27
00869732000128Persyst 14 Review and Analysis SoftwarePersyst Development CorpOMB2019-04-08
00869732000135Persyst Mobile App Persyst Development CorpOMB2019-04-08
00869732000142Persyst Mobile AppPersyst Development CorpOMB2019-04-08
00851420007045Pocket EEG Device, EEG Recording Viewer SoftwareCERIBELL, INC.OMB2018-03-28
00382830022231XLTEKXLTEKOMB2016-10-17
00382830002493NatusXLTEKOMB2016-09-13
00382830002516NatusXLTEKOMB2016-09-13
00382830002523NatusXLTEKOMB2016-09-13
00382830002547NatusXLTEKOMB2016-09-13
00382830002554NatusXLTEKOMB2016-09-13
00382830002677NatusXLTEKOMB2016-09-13
00382830002745NatusXLTEKOMB2016-09-13
00382830002820NatusXLTEKOMB2016-09-13
00382830009072NatusXLTEKOMB2016-09-13
00382830016643NatusXLTEKOMB2016-09-13