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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
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