Acumen Hypotension Prediction Index (HPI) Feature Software

Adjunctive Predictive Cardiovascular Indicator

Edwards Lifesciences LLC

The following data is part of a De Novo classification by Edwards Lifesciences Llc with the FDA for Acumen Hypotension Prediction Index (hpi) Feature Software.

Pre-market Notification Details

DeNovo IDDEN160044
Device Name:Acumen Hypotension Prediction Index (HPI) Feature Software
ClassificationAdjunctive Predictive Cardiovascular Indicator
Applicant Edwards Lifesciences LLC one Edwards Way Irvine,  CA  92614
ContactLisa Gilman
Product CodeQAQ  
CFR Regulation Number870.2210 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardCardiovascular
Classification AdvisoryCardiovascular
TypeDirect
Date Received2016-09-26
Decision Date2018-03-16
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.