FDA 510(k)

Neuvotion NeuStim NN-01

K-Number: K240632 · 2024-11-22

Decision Date2024-11-22

Product CodeGZI

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Neuvotion NeuStim NN-01 is the device name listed in this FDA 510(k) record. The listed applicant is Neuvotion, Inc.. It received FDA 510(k) clearance on 2024-11-22 under 510(k) number K240632. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neuvotion NeuStim NN-01?

Neuvotion NeuStim NN-01 is a medical device that received FDA 510(k) clearance on 2024-11-22. The listed applicant is Neuvotion, Inc.. The 510(k) number is K240632.

When did Neuvotion NeuStim NN-01 receive FDA 510(k) clearance?

Neuvotion NeuStim NN-01 received FDA 510(k) clearance on 2024-11-22, under 510(k) number K240632.

Who is the listed applicant for Neuvotion NeuStim NN-01?

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

What is the FDA product code for Neuvotion NeuStim NN-01?

The FDA product code for Neuvotion NeuStim NN-01 is GZI.

Related Devices (Code: GZI)

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.