Cleared Traditional

Persyst 15 EEG Review and Analysis Software

K222002 · Persyst Development Corporation · Neurology

Dec 2022

Decision

176d

Days

Class 2

Risk

About This 510(k) Submission

K222002 is an FDA 510(k) clearance for the Persyst 15 EEG Review and Analysis Software, a Automatic Event Detection Software For Full-montage Electroencephalograph (Class II — Special Controls, product code OMB), submitted by Persyst Development Corporation (Solana Beach, US). The FDA issued a Cleared decision on December 30, 2022, 176 days after receiving the submission on July 7, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K222002 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 07, 2022
Decision Date	December 30, 2022
Days to Decision	176 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Statement

Device Classification

Product Code	OMB — Automatic Event Detection Software For Full-montage Electroencephalograph
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	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 Subject To Verification By Qualified User