Cleared Special

PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE

K151929 · Persyst Development Corporation · Neurology

Aug 2015

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K151929 is an FDA 510(k) clearance for the PERSYST 13 (P13) 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 (San Diego, US). The FDA issued a Cleared decision on August 12, 2015, 29 days after receiving the submission on July 14, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K151929 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 14, 2015
Decision Date	August 12, 2015
Days to Decision	29 days
Submission Type	Special
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