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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 K113821
Device Name TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
Original Applicant
TRANSONIC SYSTEMS, INC.
34 dutch mill rd
ithaca,  NY  14850
Original Contact naveen thuramalla
Regulation Number870.1435
Classification Product Code
DXG  
Date Received12/27/2011
Decision Date 09/07/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Clinical Trials NCT00851422
NCT00852254
NCT01662141
Reviewed by Third Party No
Combination Product No
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