510(k) K240596

Cerebral Autoregulation Index (CAI) Algorithm by Edwards Lifesciences — Product Code MUD

K240596 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences for the device "Cerebral Autoregulation Index (CAI) Algorithm". The FDA issued a decision of Substantially Equivalent on October 16, 2024. The device falls under product code MUD (Oximeter, Tissue Saturation), a Class II device regulated under 21 CFR 870.2700. Edwards Lifesciences has at least 10 other 510(k) clearances on record.