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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medium-Term Adjunctive Predictive Cardiovascular Indicator
510(k) Number K231038
Device Name Global Hypoperfusion Index (GHI) Algorithm
Applicant
Edwards Lifesciences, LLC
1 Edwards Way
Irvine,  CA  92614
Applicant Contact Michelle Ducca
Correspondent
Edwards Lifesciences, LLC
1 Edwards Way
Irvine,  CA  92614
Correspondent Contact Michelle Ducca
Regulation Number870.2210
Classification Product Code
QNL  
Date Received04/12/2023
Decision Date 07/26/2023
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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