Ceribell Instant EEG Headset
K-Number: K254033 · 2026-02-09
ApplicantCeribell, Inc.
Decision Date2026-02-09
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Ceribell Instant EEG Headset is a medical device manufactured by Ceribell, Inc.. It received FDA 510(k) clearance on 2026-02-09 under approval number K254033. 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 Instant EEG Headset?
Ceribell Instant EEG Headset is a medical device that received FDA 510(k) clearance on 2026-02-09. It is manufactured by Ceribell, Inc.. The 510(k) number is K254033.
When was Ceribell Instant EEG Headset approved by the FDA?
Ceribell Instant EEG Headset received FDA 510(k) clearance on 2026-02-09, under approval number K254033.
What company makes Ceribell Instant EEG Headset?
Ceribell Instant EEG Headset is manufactured by Ceribell, Inc..
What is the FDA product code for Ceribell Instant EEG Headset?
The FDA product code for Ceribell Instant EEG Headset 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.