Ceribell Instant EEG Headband

Ceribell Instant EEG Headband is an FDA 510(k)-cleared medical device (K210805) 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 August 29, 2021. Regulation: 8.