Persyst 15 EEG Review and Analysis Software

Persyst 15 EEG Review and Analysis Software is an FDA 510(k)-cleared medical device (K222002) manufactured by Persyst Development Corporation. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 29, 2022. Regulation: 8.