FDA 510(k)

Evo® sEEG System

K-Number: K222404 · 2022-10-20

ApplicantNeuroone Medical Technologies Corp.

Decision Date2022-10-20

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 2022-10-20 under approval number K222404. 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 2022-10-20. It is manufactured by Neuroone Medical Technologies Corp.. The 510(k) number is K222404.

When was Evo® sEEG System approved by the FDA?

Evo® sEEG System received FDA 510(k) clearance on 2022-10-20, under approval number K222404.

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.

K211367Evo 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.