Cleared Traditional

Persyst 14 EEG Review and Analysis Software

K182181 · Persyst Development Corporation · Neurology

Nov 2018

Decision

108d

Days

Class 2

Risk

About This 510(k) Submission

K182181 is an FDA 510(k) clearance for the Persyst 14 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 November 29, 2018, 108 days after receiving the submission on August 13, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K182181 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 13, 2018
Decision Date	November 29, 2018
Days to Decision	108 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