Cleared Traditional

Neuron-Spectrum-AM with Neuron-Spectrum.NET Software

K220254 · Neurosoft , Ltd. · Neurology

Nov 2022

Decision

303d

Days

Class 2

Risk

About This 510(k) Submission

K220254 is an FDA 510(k) clearance for the Neuron-Spectrum-AM with Neuron-Spectrum.NET Software, a Non-normalizing Quantitative Electroencephalograph Software (Class II — Special Controls, product code OLT), submitted by Neurosoft , Ltd. (Ivanovo, RU). The FDA issued a Cleared decision on November 30, 2022, 303 days after receiving the submission on January 31, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K220254 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 31, 2022
Decision Date	November 30, 2022
Days to Decision	303 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.