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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 K161245
Device Name EP-TRACER System
Applicant
Cardio Tek, BV
Amerikalaan 70
Ae Maastricht-Airport Limburg,  NL 6199
Applicant Contact OLIVER ROTH
Correspondent
Graematter, Inc.
1324 Clarkson Clayton Center
St Louis,  MO  63011
Correspondent Contact MELISSA WALKER
Regulation Number870.1425
Classification Product Code
DQK  
Date Received05/03/2016
Decision Date 08/05/2016
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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