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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, Physiological Signal, Radiofrequency
510(k) Number K150289
Device Name CARDIOLINE HD+
Applicant
Cardioline S.P.A
Via De Zinis, 6
Cavareno,  TN  38011
Applicant Contact Emanuele Ercoli
Correspondent
Cardioline S.P.A
Via De Zinis, 6
Cavareno,  TN  38011
Correspondent Contact Emanuele Ercoli
Regulation Number870.2910
Classification Product Code
DRG  
Date Received02/05/2015
Decision Date 08/27/2015
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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