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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 K131588
Device Name VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR
Applicant
EDWARDS LIFESCIENCES, LLC.
ONE EDWARDS WAY
IRVINE,  CA  92614
Applicant Contact SALLY MAHER
Correspondent
EDWARDS LIFESCIENCES, LLC.
ONE EDWARDS WAY
IRVINE,  CA  92614
Correspondent Contact SALLY MAHER
Regulation Number870.1435
Classification Product Code
DXG  
Subsequent Product Code
DQE  
Date Received05/31/2013
Decision Date 05/22/2014
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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