K-number	K233984
Device name	Acumen Assisted Fluid Management (AFM) Software Feature
Applicant	Edwards Lifesciences, LLC
Product code	QMS
Device class	Class II
Decision date	Aug 2, 2024
Decision	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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