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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 a medical device manufactured by Ceribell, Inc.. It received FDA 510(k) clearance on 2026-04-03 under approval 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. It is manufactured by Ceribell, Inc.. The 510(k) number is K260363.

When was Ceribell Brain Monitor Headband approved by the FDA?

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

What company makes Ceribell Brain Monitor Headband?

Ceribell Brain Monitor Headband is manufactured by Ceribell, Inc..

What is the FDA product code for Ceribell Brain Monitor Headband?

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

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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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