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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
Cardiologs Technologies
15 rue I'Ecole de Medecine
Paris,  FR 75006
Applicant Contact Quentin de Snoeck
Daniel & Daniel Consulting, LLC
34 Jones Lane
Gardnerville,  NV  89460
Correspondent Contact Michael A. Daniel
Regulation Number870.2340
Classification Product Code
Subsequent Product Code
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