FDA 510(k)

NeuroSwift Pro

Número K: K223047 · 2023-06-29

RequerenteNeurobit Technologies Co., Ltd.

Data da decisão2023-06-29

Código do produtoGWN

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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