Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))

Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) is an FDA 510(k)-cleared medical device (K252160) manufactured by Persyst Development, LLC. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 30, 2025. Regulation: 8.