Cleared Traditional

GALILEO NT

K142064 · Eb Neuro S.P.A. · Neurology

Feb 2015

Decision

198d

Days

Class 2

Risk

About This 510(k) Submission

K142064 is an FDA 510(k) clearance for the GALILEO NT, a Non-normalizing Quantitative Electroencephalograph Software (Class II — Special Controls, product code OLT), submitted by Eb Neuro S.P.A. (Indianpolis, US). The FDA issued a Cleared decision on February 13, 2015, 198 days after receiving the submission on July 30, 2014. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K142064 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 30, 2014
Decision Date	February 13, 2015
Days to Decision	198 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.