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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 the device name listed in this FDA 510(k) record. The listed applicant is Ceribell, Inc.. It received FDA 510(k) clearance on 2025-12-08 under 510(k) 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. The listed applicant is Ceribell, Inc.. The 510(k) number is K251936.

When did Ceribell Delirium Monitor System receive FDA 510(k) clearance?

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

Who is the listed applicant for Ceribell Delirium Monitor System?

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

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07449416Ceribell Delirium Monitor Outcomes Pilot StudyRECRUITINGNCT07485244EEG Abnormalities in Adult ICU Patients With High Risk of DeliriumRECRUITING

Other records listing Ceribell, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261101Ceribell MonitorK260998Ceribell Neurology Review SoftwareK260363Ceribell Brain Monitor HeadbandK254033Ceribell Instant EEG HeadsetK252070Ceribell Infant Seizure Detection SoftwareK251381Ceribell Instant EEG Headcap (Small: C251, Medium: C252)

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Related Devices (Code: NCG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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