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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 K221704
Device Name HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI)
Applicant
Edwards Lifesciences, LLC
1 Edwards Way
Irvine,  CA  92614
Applicant Contact Michelle Ducca
Correspondent
Edwards Lifesciences, LLC
1 Edwards Way
Irvine,  CA  92614
Correspondent Contact Michelle Ducca
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Codes
DQR   DSB   DXN   MUD   QAQ  
Date Received06/13/2022
Decision Date 11/22/2022
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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