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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 K230057
Device Name Acumen Hypotension Prediction Index (HPI) Algorithm
Applicant
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92614
Applicant Contact Varad Raghuwanshi
Correspondent
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92614
Correspondent Contact Varad Raghuwanshi
Regulation Number870.2210
Classification Product Code
QAQ  
Date Received01/09/2023
Decision Date 06/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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