FDA 510(k)

Evo sEEG System

K-Number: K211367 · 2021-09-01

ApplicantNeuroone Medical Technologies Corp.

Decision Date2021-09-01

Product CodeGZL

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Evo sEEG System is a medical device manufactured by Neuroone Medical Technologies Corp.. It received FDA 510(k) clearance on 2021-09-01 under approval number K211367. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Evo sEEG System?

Evo sEEG System is a medical device that received FDA 510(k) clearance on 2021-09-01. It is manufactured by Neuroone Medical Technologies Corp.. The 510(k) number is K211367.

When was Evo sEEG System approved by the FDA?

Evo sEEG System received FDA 510(k) clearance on 2021-09-01, under approval number K211367.

What company makes Evo sEEG System?

Evo sEEG System is manufactured by Neuroone Medical Technologies Corp..

What is the FDA product code for Evo sEEG System?

The FDA product code for Evo sEEG System is GZL.

Other Devices by Neuroone Medical Technologies Corp.

K222404Evo® sEEG System K231675OneRF Ablation System K251243OneRF Trigeminal Nerve Radiofrequency Probes

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.