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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 K150990
Device Name ECVUE Mapping System
Applicant
Cardioinsight Technologies, Inc.
11000 Cedar Ave. Suite 210
Cleveland,  OH  44106
Applicant Contact Christina V Vacca
Correspondent
Cardioinsight Technologies, Inc.
11000 Cedar Ave. Suite 210
Cleveland,  OH  44106
Correspondent Contact Christina V Vacca
Regulation Number870.1425
Classification Product Code
DQK  
Date Received04/15/2015
Decision Date 07/02/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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