FDA 510(k) Applications Submitted by Sara Pesian

FDA 510(k) Number Submission Date Device Name Applicant
K223651 12/06/2022 Cerebral Adaptive Index (CAI) Algorithm Edwards Lifesciences, LLC
K223865 12/23/2022 HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor Edwards Lifesciences, LLC


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