510(k) K223651

Cerebral Adaptive Index (CAI) Algorithm by Edwards Lifesciences, LLC — Product Code MUD

K223651 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "Cerebral Adaptive Index (CAI) Algorithm". The FDA issued a decision of Substantially Equivalent on May 26, 2023. The device falls under product code MUD (Oximeter, Tissue Saturation), a Class II device regulated under 21 CFR 870.2700. Edwards Lifesciences, LLC has at least 10 other 510(k) clearances on record.