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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph, Ambulatory (Without Analysis)
510(k) Number K210758
Device Name Q Patch
Applicant
Medicalgorithmics S.A.
Aleje Jerozolimskie 81
Warsaw,  PL 02-001
Applicant Contact Maciej Gamrot
Correspondent
Medicalgorithmics US Holding Corporation
Corporation Service Company 251 Little Falls Dr.
Wilmington,  DE  19808
Correspondent Contact Agnieszka Romowicz
Regulation Number870.2800
Classification Product Code
MWJ  
Date Received03/15/2021
Decision Date 06/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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