510(k) K223865

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 by Edwards Lifesciences, LLC — Product Code DQK

K223865 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "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". The FDA issued a decision of Substantially Equivalent on June 9, 2023. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Edwards Lifesciences, LLC has at least 10 other 510(k) clearances on record.