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FDA 510(k)

Ceribell Brain Monitor Headband

K-Number: K260363 · 2026-04-03

ApplicantCeribell, Inc.
Decision Date2026-04-03
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Ceribell Brain Monitor Headband is the device name listed in this FDA 510(k) record. The listed applicant is Ceribell, Inc.. It received FDA 510(k) clearance on 2026-04-03 under 510(k) number K260363. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ceribell Brain Monitor Headband?

Ceribell Brain Monitor Headband is a medical device that received FDA 510(k) clearance on 2026-04-03. The listed applicant is Ceribell, Inc.. The 510(k) number is K260363.

When did Ceribell Brain Monitor Headband receive FDA 510(k) clearance?

Ceribell Brain Monitor Headband received FDA 510(k) clearance on 2026-04-03, under 510(k) number K260363.

Who is the listed applicant for Ceribell Brain Monitor Headband?

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 Brain Monitor Headband?

The FDA product code for Ceribell Brain Monitor Headband is GXY.

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 StudyRECRUITING

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 SoftwareK254033Ceribell Instant EEG HeadsetK251936Ceribell Delirium Monitor SystemK252070Ceribell Infant Seizure Detection SoftwareK251381Ceribell Instant EEG Headcap (Small: C251, Medium: C252)

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Related Devices (Code: GXY)

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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