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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 K211465
Device Name HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform
Applicant
Edwards Lfesciences
One Edwards Way
Irvine,  CA  92614
Applicant Contact Chirag Shah
Correspondent
Edwards Lfesciences
One Edwards Way
Irvine,  CA  92614
Correspondent Contact Chirag Shah
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Codes
DQE   DSB   DXN   MUD   QAQ  
Date Received05/11/2021
Decision Date 07/08/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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