FDA 510(k)

Neuronaute Plus

K-Number: K231366 · 2023-11-09

Decision Date2023-11-09

Product CodeGWQ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Neuronaute Plus is the device name listed in this FDA 510(k) record. The listed applicant is Bioserenity Sas. It received FDA 510(k) clearance on 2023-11-09 under 510(k) 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. The listed applicant is Bioserenity Sas. The 510(k) number is K231366.

When did Neuronaute Plus receive FDA 510(k) clearance?

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

Who is the listed applicant for Neuronaute Plus?

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

What is the FDA product code for Neuronaute Plus?

The FDA product code for Neuronaute Plus is GWQ.

Other records listing Bioserenity Sas 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.

K202334Neuronaute K173248CARDIOSKIN

Related Devices (Code: GWQ)

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, Inc.K221963Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited

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.