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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K152550
Device Name MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM
Applicant
Medicalgorithmics S.A.
Ai. Jerozolimskie 81
Warsaw,  PL 02-001
Applicant Contact MAREK J. DZIUBINSKI
Correspondent
Medicalgorithmics, LLC
245 W. 107th St.
Suite 11 A
New York,  NY  10025
Correspondent Contact MARTIN JASINSKI
Regulation Number870.1025
Classification Product Code
DSI  
Date Received09/08/2015
Decision Date 10/08/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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