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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 a medical device manufactured by Neurobit Technologies Co., Ltd.. It received FDA 510(k) clearance on 2023-06-29 under approval 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. It is manufactured by Neurobit Technologies Co., Ltd.. The 510(k) number is K223047.

When was NeuroSwift Pro approved by the FDA?

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

What company makes NeuroSwift Pro?

NeuroSwift Pro is manufactured by Neurobit Technologies Co., Ltd..

What is the FDA product code for NeuroSwift Pro?

The FDA product code for NeuroSwift Pro is GWN.

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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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