K-number	K240596
Device name	Cerebral Autoregulation Index (CAI) Algorithm
Applicant	Edwards Lifesciences
Product code	MUD
Device class	Class II
Decision date	Oct 16, 2024
Decision	Substantially Equivalent
Regulation	870.2700

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Source

View the full FDA submission: accessdata.fda.gov

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Cerebral Autoregulation Index (CAI) Algorithm

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