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FDA 510(k)

Ceribell Delirium Monitor System

K-Number: K251936 · 2025-12-08

ApplicantCeribell, Inc.
Decision Date2025-12-08
Product CodeNCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Ceribell Delirium Monitor System is a medical device manufactured by Ceribell, Inc.. It received FDA 510(k) clearance on 2025-12-08 under approval number K251936. The device is classified under product code NCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ceribell Delirium Monitor System?

Ceribell Delirium Monitor System is a medical device that received FDA 510(k) clearance on 2025-12-08. It is manufactured by Ceribell, Inc.. The 510(k) number is K251936.

When was Ceribell Delirium Monitor System approved by the FDA?

Ceribell Delirium Monitor System received FDA 510(k) clearance on 2025-12-08, under approval number K251936.

What company makes Ceribell Delirium Monitor System?

Ceribell Delirium Monitor System is manufactured by Ceribell, Inc..

What is the FDA product code for Ceribell Delirium Monitor System?

The FDA product code for Ceribell Delirium Monitor System is NCG.

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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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