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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 K020366
Device Name GLOBAL ECG MANAGEMENT SYSTEM (GEMS)
Applicant
Cardiocomm Solutions, Inc.
3060 Cedar Hill Rd., Suite 201
Victoria, B.C.,  CA V8T 3J5
Applicant Contact ANGELA HALWAS
Correspondent
Cardiocomm Solutions, Inc.
3060 Cedar Hill Rd., Suite 201
Victoria, B.C.,  CA V8T 3J5
Correspondent Contact ANGELA HALWAS
Regulation Number870.2340
Classification Product Code
DPS  
Date Received02/04/2002
Decision Date 04/30/2002
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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