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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Outpatient Cardiac Telemetry
510(k) Number K162956
Device Name NOWCARDIO SYSTEM
Applicant
Contex International Technologies (Canada), Inc.
2798 Thamesgate Dr., Units 5&6
Mississauga,  CA L4T 4E8
Applicant Contact RICARDO RODRIGUEZ
Correspondent
Contex International Technologies (Canada), Inc.
2798 Thamesgate Dr., Units 5&6
Mississauga,  CA L4T 4E8
Correspondent Contact RICARDO RODRIGUEZ
Regulation Number870.1025
Classification Product Code
QYX  
Subsequent Product Codes
DSI   MHX  
Date Received10/24/2016
Decision Date 09/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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