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FDA 510(k)

Cerebral Adaptive Index (CAI) Algorithm

K-Number: K223651 · 2023-05-26

ApplicantEdwards Lifesciences, LLC
Decision Date2023-05-26
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cerebral Adaptive Index (CAI) Algorithm is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2023-05-26 under approval number K223651. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cerebral Adaptive Index (CAI) Algorithm?

Cerebral Adaptive Index (CAI) Algorithm is a medical device that received FDA 510(k) clearance on 2023-05-26. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K223651.

When was Cerebral Adaptive Index (CAI) Algorithm approved by the FDA?

Cerebral Adaptive Index (CAI) Algorithm received FDA 510(k) clearance on 2023-05-26, under approval number K223651.

What company makes Cerebral Adaptive Index (CAI) Algorithm?

Cerebral Adaptive Index (CAI) Algorithm is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for Cerebral Adaptive Index (CAI) Algorithm?

The FDA product code for Cerebral Adaptive Index (CAI) Algorithm is MUD.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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