Cleared Traditional

Cerebral Autoregulation Index (CAI) Algorithm

K240596 · Edwards Lifesciences · Neurology
Oct 2024
Decision
226d
Days
Class 2
Risk

About This 510(k) Submission

K240596 is an FDA 510(k) clearance for the Cerebral Autoregulation Index (CAI) Algorithm, a Oximeter, Tissue Saturation (Class II — Special Controls, product code MUD), submitted by Edwards Lifesciences (Irvine, US). The FDA issued a Cleared decision on October 16, 2024, 226 days after receiving the submission on March 4, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K240596 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2024
Decision Date October 16, 2024
Days to Decision 226 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code MUD — Oximeter, Tissue Saturation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700

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