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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K134044
Device Name EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM
Applicant
Cardio Tek, BV
1324 Clarkson Clayton Center #332
Ballwin,  MO  6301
Applicant Contact MELISSA WALKER
Correspondent
Cardio Tek, BV
1324 Clarkson Clayton Center #332
Ballwin,  MO  6301
Correspondent Contact MELISSA WALKER
Regulation Number870.1425
Classification Product Code
DQK  
Date Received12/31/2013
Decision Date 03/31/2014
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
Recalls CDRH Recalls
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