Cleared Traditional

K142834 - DiscoverEEG System, Model DE-401
(FDA 510(k) Clearance)

K142834 · Neurowave Systems, Inc. · Neurology

Jun 2015

Decision

266d

Days

Class 2

Risk

K142834 is an FDA 510(k) clearance for the DiscoverEEG System, Model DE-401. This device is classified as a Non-normalizing Quantitative Electroencephalograph Software (Class II — Special Controls, product code OLT).

Submitted by Neurowave Systems, Inc. (Cleveland Heights, US). The FDA issued a Cleared decision on June 23, 2015, 266 days after receiving the submission on September 30, 2014.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1400. Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User..

Submission Details

510(k) Number	K142834 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2014
Decision Date	June 23, 2015
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OLT — Non-normalizing Quantitative Electroencephalograph Software
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User.