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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 the device name listed in this FDA 510(k) record. The listed applicant is Neurosoft , Ltd.. It received FDA 510(k) clearance on 2021-05-22 under 510(k) 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. The listed applicant is Neurosoft , Ltd.. The 510(k) number is K190703.

When did Neuro-IOM system with Neuro-IOM.NET software receive FDA 510(k) clearance?

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

Who is the listed applicant for Neuro-IOM system with Neuro-IOM.NET software?

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

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.

Other records listing Neurosoft , Ltd. 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.

K220254Neuron-Spectrum-AM with Neuron-Spectrum.NET Software

Related Devices (Code: GWF)

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.

K253301BraiN20® (BraiN20)Time IS Brain, S.L.K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.K243982Nicolet EDXNatus Neurology IncorporatedK243495Natus Ultrapro S100 (982A0594)Natus Neurology IncorporatedK242345Delphi StimulatorQuantalx NeuroscienceK234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, 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.

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