Cleared Traditional

PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE

K133793 · Persyst Development Corporation · Neurology

May 2014

Decision

157d

Days

Class 2

Risk

About This 510(k) Submission

K133793 is an FDA 510(k) clearance for the PERSYST 12 ( P12) EGG 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 (San Diego, US). The FDA issued a Cleared decision on May 19, 2014, 157 days after receiving the submission on December 13, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K133793 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 2013
Decision Date	May 19, 2014
Days to Decision	157 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

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