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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adjunctive Open Loop Fluid Therapy Recommender
510(k) Number K233984
Device Name Acumen Assisted Fluid Management (AFM) Software Feature
Applicant
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92614
Applicant Contact Kshama Pai
Correspondent
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92614
Correspondent Contact Kshama Pai
Regulation Number870.5600
Classification Product Code
QMS  
Date Received12/18/2023
Decision Date 08/02/2024
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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