Ceribell Instant EEG Headset

Ceribell Instant EEG Headset is an FDA 510(k)-cleared medical device (K254033) manufactured by Ceribell, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 8, 2026. Regulation: 8.