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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 K143432
Device Name Cardio-TriTest
Applicant
Cardio-Phoenix, Inc.
2102-65 Spring Garden Ave.
Toronto,  CA M2N 6H9
Applicant Contact MARC BISNAIRE
Correspondent
Cardio-Phoenix, Inc.
2102-65 Spring Garden Ave.
Toronto,  CA M2N 6H9
Correspondent Contact MARC BISNAIRE
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Codes
DQC   DXR  
Date Received12/01/2014
Decision Date 06/03/2015
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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