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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
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