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 the device name listed in this FDA 510(k) record. The listed applicant is Neuroone Medical Technologies Corp.. It received FDA 510(k) clearance on 2021-09-01 under 510(k) 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. The listed applicant is Neuroone Medical Technologies Corp.. The 510(k) number is K211367.

When did Evo sEEG System receive FDA 510(k) clearance?

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

Who is the listed applicant for Evo sEEG System?

The FDA 510(k) record lists Neuroone Medical Technologies Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Evo sEEG System?

The FDA product code for Evo sEEG System is GZL.

Other records listing Neuroone Medical Technologies Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

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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.