Ceribell Instant EEG Headcap

Ceribell Instant EEG Headcap is an FDA 510(k)-cleared medical device (K223086) 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 March 21, 2023. Regulation: 8.