K-number	DEN190029
Device name	Acumen Assisted Fluid Management (AFM) Software Feature
Applicant	Edwards Lifesciences
Product code	QMS
Device class	Class II
Decision date	Nov 13, 2020
Decision	Not Substantially Equivalent
Regulation	870.5600

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Source

View the full FDA submission: accessdata.fda.gov

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Acumen Assisted Fluid Management (AFM) Software Feature

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