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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
Model MODEL 99
Device Name CARDIOX FLOW DETECTION SYSTEM
Original Applicant
CARDIOX CORP.
4100 horizons drive, suite 100
columbus,  OH  43220
Original Contact karen matis
Regulation Number870.1435
Classification Product Code
DXG  
Date Received08/07/2012
Decision Date 11/05/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product Yes
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