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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 K124060
Device Name MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
Applicant
Medicalgorithmics S.A.
245 W. 107th St.
Suite 11 A
New York,  NY  10025
Applicant Contact MARTIN JASINSKI
Correspondent
Medicalgorithmics S.A.
245 W. 107th St.
Suite 11 A
New York,  NY  10025
Correspondent Contact MARTIN JASINSKI
Regulation Number870.1025
Classification Product Code
DSI  
Date Received12/31/2012
Decision Date 02/21/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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