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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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