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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K223865
Device Name HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor
Applicant
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92614
Applicant Contact Sara Pesian
Correspondent
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92614
Correspondent Contact Sara Pesian
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Codes
DQE   DSB   DXN   FLL   MUD  
QAQ   QMS  
Date Received12/23/2022
Decision Date 06/09/2023
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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