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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 K081776
FOIA Releasable 510(k) K081776
Device Name CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM
Applicant
Omega Critical Care Limited
Omega House, 2 Cairn Ct.
Nerston W.
East Kilbride,  GB G74 4NB
Applicant Contact ALAN SHORT
Correspondent
Omega Critical Care Limited
Omega House, 2 Cairn Ct.
Nerston W.
East Kilbride,  GB G74 4NB
Correspondent Contact ALAN SHORT
Regulation Number870.1435
Classification Product Code
DXG  
Date Received06/23/2008
Decision Date 07/22/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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