Cleared Traditional

Persyst Mobile App

K171184 · Persyst Development Corporation · Neurology

Sep 2017

Decision

150d

Days

Class 2

Risk

About This 510(k) Submission

K171184 is an FDA 510(k) clearance for the Persyst Mobile App, 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 September 21, 2017, 150 days after receiving the submission on April 24, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K171184 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 24, 2017
Decision Date	September 21, 2017
Days to Decision	150 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