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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
Prolira B.V.
Padualaan 8
Utrecht,  NL 3584 CH
Applicant Contact Rutger O. van Merkerk
Corolla Clin/Reg Consulting
481 Spindrift Trail #696
Corolla,  NC  23059
Correspondent Contact Paul J Manberg
Regulation Number882.1440
Classification Product Code
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