K-number	K203490
Device name	FORE-SIGHT ELITE Absolute Tissue Oximeter
Applicant	Edwards Lifesciences, LLC
Product code	MUD
Device class	Class II
Decision date	Feb 10, 2021
Decision	Substantially Equivalent
Regulation	870.2700

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Source

View the full FDA submission: accessdata.fda.gov

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FORE-SIGHT ELITE Absolute Tissue Oximeter

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