FDA 510(k)

Cerebral Autoregulation Index (CAI) Algorithm

K-Number: K240596 · 2024-10-16

Decision Date2024-10-16

Product CodeMUD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Cerebral Autoregulation Index (CAI) Algorithm is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences. It received FDA 510(k) clearance on 2024-10-16 under 510(k) 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. The listed applicant is Edwards Lifesciences. The 510(k) number is K240596.

When did Cerebral Autoregulation Index (CAI) Algorithm receive FDA 510(k) clearance?

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

Who is the listed applicant for Cerebral Autoregulation Index (CAI) Algorithm?

The FDA 510(k) record lists Edwards Lifesciences as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Cerebral Autoregulation 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.