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FDA 510(k)

Neuronaute

K-Number: K202334 · 2020-12-10

ApplicantBioserenity Sas
Decision Date2020-12-10
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Neuronaute is a medical device manufactured by Bioserenity Sas. It received FDA 510(k) clearance on 2020-12-10 under approval number K202334. 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?

Neuronaute is a medical device that received FDA 510(k) clearance on 2020-12-10. It is manufactured by Bioserenity Sas. The 510(k) number is K202334.

When was Neuronaute approved by the FDA?

Neuronaute received FDA 510(k) clearance on 2020-12-10, under approval number K202334.

What company makes Neuronaute?

Neuronaute is manufactured by Bioserenity Sas.

What is the FDA product code for Neuronaute?

The FDA product code for Neuronaute is GWQ.

Other Devices by Bioserenity Sas

K173248CARDIOSKIN K231366Neuronaute Plus

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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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