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FDA 510(k)

Cerebral Autoregulation Index (CAI) Algorithm

K-Number: K240596 · 2024-10-16

ApplicantEdwards Lifesciences
Decision Date2024-10-16
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cerebral Autoregulation Index (CAI) Algorithm is a medical device manufactured by Edwards Lifesciences. It received FDA 510(k) clearance on 2024-10-16 under approval number K240596. 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 Autoregulation Index (CAI) Algorithm?

Cerebral Autoregulation Index (CAI) Algorithm is a medical device that received FDA 510(k) clearance on 2024-10-16. It is manufactured by Edwards Lifesciences. The 510(k) number is K240596.

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

Cerebral Autoregulation Index (CAI) Algorithm received FDA 510(k) clearance on 2024-10-16, under approval number K240596.

What company makes Cerebral Autoregulation Index (CAI) Algorithm?

Cerebral Autoregulation Index (CAI) Algorithm is manufactured by Edwards Lifesciences.

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

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

Related Clinical Trials

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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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