Persyst 15 EEG Review and Analysis Software

K222002 is the FDA 510(k) clearance record for Persyst 15 EEG Review and Analysis Software, a class II device, cleared for Persyst Development Corporation on 2022-12-30 under FDA product code OMB (Automatic Event Detection Software For Full-Montage Electroencephalograph). FDA's definition for product code OMB reads: "Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output...". FDA records list 11 510(k) clearances for Persyst Development Corporation, from 1998-03-09 to 2025-10-31. As of 2026-09-10, FDA records show no recalls naming K222002.