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FDA 510(k)

Neuro Omega System

K-Number: K171581 · 2017-12-22

ApplicantAlpha Omega Engineering , Ltd.
Decision Date2017-12-22
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Neuro Omega System is a medical device manufactured by Alpha Omega Engineering , Ltd.. It received FDA 510(k) clearance on 2017-12-22 under approval number K171581. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neuro Omega System?

Neuro Omega System is a medical device that received FDA 510(k) clearance on 2017-12-22. It is manufactured by Alpha Omega Engineering , Ltd.. The 510(k) number is K171581.

When was Neuro Omega System approved by the FDA?

Neuro Omega System received FDA 510(k) clearance on 2017-12-22, under approval number K171581.

What company makes Neuro Omega System?

Neuro Omega System is manufactured by Alpha Omega Engineering , Ltd..

What is the FDA product code for Neuro Omega System?

The FDA product code for Neuro Omega System is GZL.

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Other Devices by Alpha Omega Engineering , Ltd.

K172042NeuroNav System, NeuroSmart System K191739Sterile LeadConfirm K220553Neuro Omega System, NeuroSmart System K250601Neuro Omega System; NeuroSmart System

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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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