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FDA 510(k)

Neuronaute Plus

K-Number: K231366 · 2023-11-09

ApplicantBioserenity Sas
Decision Date2023-11-09
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Neuronaute Plus is a medical device manufactured by Bioserenity Sas. It received FDA 510(k) clearance on 2023-11-09 under approval number K231366. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neuronaute Plus?

Neuronaute Plus is a medical device that received FDA 510(k) clearance on 2023-11-09. It is manufactured by Bioserenity Sas. The 510(k) number is K231366.

When was Neuronaute Plus approved by the FDA?

Neuronaute Plus received FDA 510(k) clearance on 2023-11-09, under approval number K231366.

What company makes Neuronaute Plus?

Neuronaute Plus is manufactured by Bioserenity Sas.

What is the FDA product code for Neuronaute Plus?

The FDA product code for Neuronaute Plus is GWQ.

Other Devices by Bioserenity Sas

K173248CARDIOSKIN K202334Neuronaute

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Official Source

View on FDA Database →

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

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