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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 K182790
Device Name Cardio-TriTest v6.5
Applicant
Cardio-Phoenix Inc.
44 Rosemead Close
Markham,  CA L3R 3Z3
Applicant Contact Marc Bisnaire
Correspondent
Cardio-Phoenix Inc.
44 Rosemead Close
Markham,  CA L3R 3Z3
Correspondent Contact Marc Bisnaire
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Codes
DQC   DXR  
Date Received10/01/2018
Decision Date 12/14/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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