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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K170568
Device Name CardioLogs ECG Analysis Platform
Applicant
Cardiologs Technologies
15 rue I'Ecole de Medecine
Paris,  FR 75006
Applicant Contact Quentin de Snoeck
Correspondent
Daniel & Daniel Consulting, LLC
34 Jones Lane
Gardnerville,  NV  89460
Correspondent Contact Michael A. Daniel
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Code
DQK  
Date Received02/27/2017
Decision Date 06/26/2017
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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