FDA 510(k)

NEURONAUTE

K-Number: K170138 · 2017-12-26

Decision Date2017-12-26

Product CodeGWQ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

NEURONAUTE is the device name listed in this FDA 510(k) record. The listed applicant is Bioserenity. It received FDA 510(k) clearance on 2017-12-26 under 510(k) number K170138. 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 2017-12-26. The listed applicant is Bioserenity. The 510(k) number is K170138.

When did NEURONAUTE receive FDA 510(k) clearance?

NEURONAUTE received FDA 510(k) clearance on 2017-12-26, under 510(k) number K170138.

Who is the listed applicant for NEURONAUTE?

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

What is the FDA product code for NEURONAUTE?

The FDA product code for NEURONAUTE is GWQ.

Other records listing Bioserenity 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.

K223644Neuronaute with IceCap 2 & IceCap 2 Small

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.K231366Neuronaute PlusBioserenity Sas K221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, Inc.

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.