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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adjunctive Predictive Cardiovascular Indicator
510(k) Number K183646
Device Name Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure
Applicant
Edwards Lifeciences, LLC
One Edwards Way
Irvine,  CA  92614
Applicant Contact Lisa Gilman
Correspondent
Edwards Lifeciences, LLC
One Edwards Way
Irvine,  CA  92614
Correspondent Contact Lisa Gilman
Regulation Number870.2210
Classification Product Code
QAQ  
Date Received12/26/2018
Decision Date 05/21/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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