Cleared Traditional

E-EEGX, N-EEGX

K191322 · GE Healthcare Finland Oy · Neurology

Jan 2020

Decision

252d

Days

Class 2

Risk

About This 510(k) Submission

K191322 is an FDA 510(k) clearance for the E-EEGX, N-EEGX, a Non-normalizing Quantitative Electroencephalograph Software (Class II — Special Controls, product code OLT), submitted by GE Healthcare Finland Oy (Helsinki, FI). The FDA issued a Cleared decision on January 22, 2020, 252 days after receiving the submission on May 15, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K191322 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 15, 2019
Decision Date	January 22, 2020
Days to Decision	252 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.