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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 K201446
Device Name HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module
Applicant
Edwards Lifesiences, LLC
One Edwards Way
Irvine,  CA  92614
Applicant Contact Varad Raghuwanshi
Correspondent
Edwards Lifesiences, LLC
One Edwards Way
Irvine,  CA  92614
Correspondent Contact Varad Raghuwanshi
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Codes
DQE   DSB   DXN   MUD   QAQ  
Date Received06/01/2020
Decision Date 10/01/2020
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
Recalls CDRH Recalls
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