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FDA 510(k)

Neuro-IOM system with Neuro-IOM.NET software

K-Number: K190703 · 2021-05-22

ApplicantNeurosoft , Ltd.
Decision Date2021-05-22
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Neuro-IOM system with Neuro-IOM.NET software is a medical device manufactured by Neurosoft , Ltd.. It received FDA 510(k) clearance on 2021-05-22 under approval number K190703. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neuro-IOM system with Neuro-IOM.NET software?

Neuro-IOM system with Neuro-IOM.NET software is a medical device that received FDA 510(k) clearance on 2021-05-22. It is manufactured by Neurosoft , Ltd.. The 510(k) number is K190703.

When was Neuro-IOM system with Neuro-IOM.NET software approved by the FDA?

Neuro-IOM system with Neuro-IOM.NET software received FDA 510(k) clearance on 2021-05-22, under approval number K190703.

What company makes Neuro-IOM system with Neuro-IOM.NET software?

Neuro-IOM system with Neuro-IOM.NET software is manufactured by Neurosoft , Ltd..

What is the FDA product code for Neuro-IOM system with Neuro-IOM.NET software?

The FDA product code for Neuro-IOM system with Neuro-IOM.NET software is GWF.

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Other Devices by Neurosoft , Ltd.

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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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