Cleared Traditional

Evo sEEG System

K211367 · Neuroone Medical Technologies Corp. · Neurology
Sep 2021
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K211367 is an FDA 510(k) clearance for the Evo sEEG System, a Electrode, Depth (Class II — Special Controls, product code GZL), submitted by Neuroone Medical Technologies Corp. (Eden Prairie, US). The FDA issued a Cleared decision on September 1, 2021, 120 days after receiving the submission on May 4, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1330.

Submission Details

510(k) Number K211367 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 2021
Decision Date September 01, 2021
Days to Decision 120 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GZL — Electrode, Depth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1330

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