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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Blood-Pressure, Extravascular
510(k) Number K043065
Device Name VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P
Applicant
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92614
Applicant Contact JASON SMITH
Correspondent
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92614
Correspondent Contact JASON SMITH
Regulation Number870.2850
Classification Product Code
DRS  
Subsequent Product Code
DXG  
Date Received11/05/2004
Decision Date 01/26/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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