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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, Pre-Programmed, Single-Function
510(k) Number K122400
Device Name CARDIOX FLOW DETECTION SYSTEM
Applicant
Cardiox Corp.
4100 Horizons Dr. Suite 100
Columbus,  OH  43220
Applicant Contact KAREN MATIS
Correspondent
Cardiox Corp.
4100 Horizons Dr. Suite 100
Columbus,  OH  43220
Correspondent Contact KAREN MATIS
Regulation Number870.1435
Classification Product Code
DXG  
Date Received08/07/2012
Decision Date 11/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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