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FDA 510(k)

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

K-Number: K220254 · 2022-11-30

ApplicantNeurosoft , Ltd.
Decision Date2022-11-30
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Neuron-Spectrum-AM with Neuron-Spectrum.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 2022-11-30 under 510(k) number K220254. The device is classified under product code OLT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neuron-Spectrum-AM with Neuron-Spectrum.NET Software?

Neuron-Spectrum-AM with Neuron-Spectrum.NET Software is a medical device that received FDA 510(k) clearance on 2022-11-30. The listed applicant is Neurosoft , Ltd.. The 510(k) number is K220254.

When did Neuron-Spectrum-AM with Neuron-Spectrum.NET Software receive FDA 510(k) clearance?

Neuron-Spectrum-AM with Neuron-Spectrum.NET Software received FDA 510(k) clearance on 2022-11-30, under 510(k) number K220254.

Who is the listed applicant for Neuron-Spectrum-AM with Neuron-Spectrum.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 Neuron-Spectrum-AM with Neuron-Spectrum.NET Software?

The FDA product code for Neuron-Spectrum-AM with Neuron-Spectrum.NET Software is OLT.

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.

K190703Neuro-IOM system with Neuro-IOM.NET software

Related Devices (Code: OLT)

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.

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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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