Cleared Traditional

NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE

K133995 · Neurosoft , Ltd. · Neurology

Jun 2015

Decision

540d

Days

Class 2

Risk

About This 510(k) Submission

K133995 is an FDA 510(k) clearance for the NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE, a Non-normalizing Quantitative Electroencephalograph Software (Class II — Special Controls, product code OLT), submitted by Neurosoft , Ltd. (Abano Terme, Padova, IT). The FDA issued a Cleared decision on June 19, 2015, 540 days after receiving the submission on December 26, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K133995 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 26, 2013
Decision Date	June 19, 2015
Days to Decision	540 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.