FDA 510(k)

NeuroSwift Pro

K-Number: K223047 · 2023-06-29

ApplicantNeurobit Technologies Co., Ltd.

Decision Date2023-06-29

Product CodeGWN

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

NeuroSwift Pro is the device name listed in this FDA 510(k) record. The listed applicant is Neurobit Technologies Co., Ltd.. It received FDA 510(k) clearance on 2023-06-29 under 510(k) number K223047. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeuroSwift Pro?

NeuroSwift Pro is a medical device that received FDA 510(k) clearance on 2023-06-29. The listed applicant is Neurobit Technologies Co., Ltd.. The 510(k) number is K223047.

When did NeuroSwift Pro receive FDA 510(k) clearance?

NeuroSwift Pro received FDA 510(k) clearance on 2023-06-29, under 510(k) number K223047.

Who is the listed applicant for NeuroSwift Pro?

The FDA 510(k) record lists Neurobit Technologies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NeuroSwift Pro?

The FDA product code for NeuroSwift Pro is GWN.

Related Devices (Code: GWN)

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.

K260566SMARTVERTIGO™ Vestibular Assessment SystemVertigoDx, Inc.K243709NeuroEars-Anna™Neuroears, Inc.K242198ICS Dizcovery (1091)Natus Medical Denmark Aps K242726Synapsys VHITInventis S.R.L.K203082Insight Infrared Video GogglesVestibular First K200534VisualEyesInteracoustics A/S

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.