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FDA 510(k)

NeuroOne Cortical Electrode

K-Number: K192764 · 2019-11-26

ApplicantNeuroone, Inc.
Decision Date2019-11-26
Product CodeGYC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NeuroOne Cortical Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Neuroone, Inc.. It received FDA 510(k) clearance on 2019-11-26 under 510(k) number K192764. The device is classified under product code GYC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeuroOne Cortical Electrode?

NeuroOne Cortical Electrode is a medical device that received FDA 510(k) clearance on 2019-11-26. The listed applicant is Neuroone, Inc.. The 510(k) number is K192764.

When did NeuroOne Cortical Electrode receive FDA 510(k) clearance?

NeuroOne Cortical Electrode received FDA 510(k) clearance on 2019-11-26, under 510(k) number K192764.

Who is the listed applicant for NeuroOne Cortical Electrode?

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

What is the FDA product code for NeuroOne Cortical Electrode?

The FDA product code for NeuroOne Cortical Electrode is GYC.

Related Devices (Code: GYC)

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.

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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.

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