Cleared Traditional

Neuro-IOM system with Neuro-IOM.NET software

K190703 · Neurosoft , Ltd. · Neurology

May 2021

Decision

796d

Days

Class 2

Risk

About This 510(k) Submission

K190703 is an FDA 510(k) clearance for the Neuro-IOM system with Neuro-IOM.NET software, a Stimulator, Electrical, Evoked Response (Class II — Special Controls, product code GWF), submitted by Neurosoft , Ltd. (Ivanovo, RU). The FDA issued a Cleared decision on May 22, 2021, 796 days after receiving the submission on March 18, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1870.

Submission Details

510(k) Number	K190703 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 18, 2019
Decision Date	May 22, 2021
Days to Decision	796 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF