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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 K223127
Device Name HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable
Applicant
Edwards Lifeciences, LLC
1 Edwards Way
Irvine,  CA  92614
Applicant Contact Michelle Ducca
Correspondent
Edwards Lifeciences, LLC
1 Edwards Way
Irvine,  CA  92614
Correspondent Contact Michelle Ducca
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Codes
DQE   DSB   DXN   MUD   QAQ  
QMS  
Date Received10/03/2022
Decision Date 11/07/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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