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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K221833
Device Name HemoSphere Advanced Monitor, HemoSphere ClearSight Module
Applicant
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92614
Applicant Contact Varad Raghuwanshi
Correspondent
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92614
Correspondent Contact Varad Raghuwanshi
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Codes
DQE   DQK   DSB   MUD  
Date Received06/23/2022
Decision Date 11/07/2022
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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