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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter, Tissue Saturation
510(k) Number K240596
Device Name Cerebral Autoregulation Index (CAI) Algorithm
Applicant
Edwards Lifesciences
One Edwards Way
Irvine,  CA  92614
Applicant Contact Daphney Germain-Kolawole
Correspondent
Edwards Lifesciences
One Edwards Way
Irvine,  CA  92614
Correspondent Contact Daphney Germain-Kolawole
Regulation Number870.2700
Classification Product Code
MUD  
Subsequent Product Code
QEM  
Date Received03/04/2024
Decision Date 10/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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