Ceribell Instant EEG Headcap (Small: C251, Medium: C252)

About This 510(k) Submission

K251381 is an FDA 510(k) clearance for the Ceribell Instant EEG Headcap (Small: C251, Medium: C252), a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Ceribell, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on October 31, 2025, 182 days after receiving the submission on May 2, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.