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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name automatic event detection software for full-montage electroencephalograph
510(k) Number K231068
Device Name autoSCORE
Holberg EEG AS
Fjøsangerveien 70A
Bergen,  NO 5068
Applicant Contact Smriti Franklin
Holberg EEG AS
Fjøsangerveien 70A
Bergen,  NO 5068
Correspondent Contact Smriti Franklin
Regulation Number882.1400
Classification Product Code
Date Received04/14/2023
Decision Date 01/07/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No