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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 K080116
Device Name TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
Applicant
TRANSONIC SYSTEMS, INC.
34 DUTCH MILL RD.
ITHACA,  NY  14850
Applicant Contact MARK S ALSBERGE
Correspondent
TRANSONIC SYSTEMS, INC.
34 DUTCH MILL RD.
ITHACA,  NY  14850
Correspondent Contact MARK S ALSBERGE
Regulation Number870.1435
Classification Product Code
DXG  
Date Received01/16/2008
Decision Date 09/08/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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