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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name adjunctive predictive cardiovascular indicator
De Novo Number DEN160044
Device Name Acumen Hypotension Prediction Index (HPI) Feature Software
Edwards Lifesciences LLC
one edwards way
irvine,  CA  92614
Contact lisa gilman
Regulation Number870.2210
Classification Product Code
Date Received09/26/2016
Decision Date 03/16/2018
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct