Evo sEEG System

FDA 510(k) K211367 · Neuroone Medical Technologies Corp.

Substantially Equivalent

510(k) numberK211367

Submission

Device name
Evo sEEG System
Applicant
Neuroone Medical Technologies Corp.
Eden Prairie, MN, US
Received
May 4, 2021
Decision date
September 1, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GZL – Electrode, Depth
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1330
Specialty
Neurology

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K222404Evo® sEEG SystemGZL · Traditional Neuroone Medical Technologies Corp.10/20/2022SE
K220553Neuro Omega System, NeuroSmart SystemGZL · Special Alpha Omega Engineering , Ltd.09/16/2022SE
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K222404Evo® sEEG SystemGZL · Traditional 10/20/2022SE

Questions and answers

When was Evo sEEG System cleared by the FDA?

Evo sEEG System (K211367) received a 510(k) decision of Substantially Equivalent on September 1, 2021, 120 days after the submission was received.

What is the product code of K211367?

The FDA product code is GZL – Electrode, Depth, a Class II (moderate risk) device regulated under 21 CFR 882.1330.