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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
510(k) Number K222680
Device Name DeltaScan Monitor
Applicant
Prolira B.V.
Padualaan 8
Utrecht,  NL 3584 CH
Applicant Contact Rutger O. van Merkerk
Correspondent
Corolla Clin/Reg Consulting
481 Spindrift Trl. #696
Corolla,  NC  23059
Correspondent Contact Paul J Manberg
Regulation Number882.1440
Classification Product Code
NCG  
Date Received09/06/2022
Decision Date 02/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT03966274
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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