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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name flowmeter, blood, cardiovascular
510(k) Number K140740
Device Name TRANSONIC TISSUE PERFUSION MONITOR
Applicant
TRANSONIC SYSTEMS, INC.
34 DUTCH MILL RD.
ITHACA,  NY  14850
Applicant Contact DAVID KLEMENTOWSKI
Correspondent
TRANSONIC SYSTEMS, INC.
34 DUTCH MILL RD.
ITHACA,  NY  14850
Correspondent Contact Leah Van De Water
Regulation Number870.2100
Classification Product Code
DPW  
Date Received03/25/2014
Decision Date 07/23/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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