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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K222671
Device Name DeltaScan Patch
Applicant
Prolira B.V.
Padualaan 8
Utrecht,  NL NL-6825 BS
Applicant Contact Rutger O. van Merkerk
Correspondent
Corolla Clin/Reg Consulting
854 Parland Pl.
Glen Allen,  VA  23059
Correspondent Contact Paul J Manberg
Regulation Number882.1320
Classification Product Code
GXY  
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
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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