K-number	K230057
Device name	Acumen Hypotension Prediction Index (HPI) Algorithm
Applicant	Edwards Lifesciences, LLC
Product code	QAQ
Device class	Class II
Decision date	Jun 8, 2023
Decision	Substantially Equivalent
Regulation	870.2210

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Source

View the full FDA submission: accessdata.fda.gov

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Acumen Hypotension Prediction Index (HPI) Algorithm

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