PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE

PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE is an FDA 510(k)-cleared medical device (K151929) 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 August 11, 2015. Regulation: 8.