VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR

Computer, Diagnostic, Pre-programmed, Single-function

EDWARDS LIFESCIENCES, LLC.

The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Vigileo Arterial Pressure Cardiac Output/oximetry Monitor; Vigileo Apco/oximetry Monitor.

Pre-market Notification Details

Device IDK131588
510k NumberK131588
Device Name:VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR
ClassificationComputer, Diagnostic, Pre-programmed, Single-function
Applicant EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine,  CA  92614
ContactSally Maher
CorrespondentSally Maher
EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine,  CA  92614
Product CodeDXG  
CFR Regulation Number870.1435 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-31
Decision Date2014-05-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00690103194760 K131588 000
00690103181418 K131588 000
00690103181449 K131588 000
00690103181456 K131588 000
00690103184976 K131588 000
00690103186093 K131588 000
00690103187267 K131588 000
00690103194586 K131588 000
00690103194593 K131588 000
00690103194609 K131588 000
00690103194616 K131588 000
00690103194722 K131588 000
00690103194739 K131588 000
00690103194746 K131588 000
00690103194753 K131588 000
00690103165418 K131588 000

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