FORE-SIGHT ELITE Absolute Tissue Oximeter

Oximeter, Tissue Saturation

Edwards Lifesciences, LLC

The following data is part of a premarket notification filed by Edwards Lifesciences, Llc with the FDA for Fore-sight Elite Absolute Tissue Oximeter.

Pre-market Notification Details

Device IDK203490
510k NumberK203490
Device Name:FORE-SIGHT ELITE Absolute Tissue Oximeter
ClassificationOximeter, Tissue Saturation
Applicant Edwards Lifesciences, LLC One Edwards Way Irvine,  CA  92614
ContactMichelle Ducca
CorrespondentMichelle Ducca
Edwards Lifesciences, LLC One Edwards Way Irvine,  CA  92614
Product CodeMUD  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-27
Decision Date2021-02-10

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