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510(k) K131588

VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR by Edwards Lifesciences, LLC — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2014
Date Received
May 31, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Device Class
Class II
Regulation Number
870.1435
Review Panel
CV
Submission Type

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