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FDA 510(k) Applications Submitted by Chirag Shah
FDA 510(k) Number
Submission Date
Device Name
Applicant
K190205
02/04/2019
HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module
Edwards Lifesciences, LLC
K180881
04/04/2018
HemoSphere Advanced Monitor, HemoSphere Pressure Cable
Edwards Lifesciences, LLC
K211465
05/11/2021
HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform
Edwards Lfesciences
K163381
12/01/2016
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable
Edwards Lifesciences, LLC
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