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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K173248
Device Name CARDIOSKIN
Applicant
Bioserenity Sas
47 Blvd. De L'Hopital
Paris,  FR 75013
Applicant Contact Quang Tran
Correspondent
Voisin Consulting Inc., Life Sciences
222 Third St.
Suite 3121
Cambridge,  MA  02142
Correspondent Contact Esin Yesilalan
Regulation Number870.2920
Classification Product Code
DXH  
Date Received10/10/2017
Decision Date 08/11/2018
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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