Cleared Traditional

EZTrack

K201910 · Neurologic, LLC · Neurology
Dec 2020
Decision
166d
Days
Class 2
Risk

About This 510(k) Submission

K201910 is an FDA 510(k) clearance for the EZTrack, a Source Localization Software For Electroencephalograph Or Magnetoencephalograph (Class II — Special Controls, product code OLX), submitted by Neurologic, LLC (Mclean, US). The FDA issued a Cleared decision on December 22, 2020, 166 days after receiving the submission on July 9, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K201910 FDA.gov
FDA Decision Cleared SESE
Date Received July 09, 2020
Decision Date December 22, 2020
Days to Decision 166 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code OLX — Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1400
Definition Correlation Of Electrical Activity Of The Brain Using Various Neuroimaging Modalities For Source-localization