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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