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FDA 510(k)

Neuro Omega System; NeuroSmart System

K-Number: K250601 · 2025-03-30

ApplicantAlpha Omega Engineering , Ltd.
Decision Date2025-03-30
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Neuro Omega System; NeuroSmart System is a medical device manufactured by Alpha Omega Engineering , Ltd.. It received FDA 510(k) clearance on 2025-03-30 under approval number K250601. 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; NeuroSmart System?

Neuro Omega System; NeuroSmart System is a medical device that received FDA 510(k) clearance on 2025-03-30. It is manufactured by Alpha Omega Engineering , Ltd.. The 510(k) number is K250601.

When was Neuro Omega System; NeuroSmart System approved by the FDA?

Neuro Omega System; NeuroSmart System received FDA 510(k) clearance on 2025-03-30, under approval number K250601.

What company makes Neuro Omega System; NeuroSmart System?

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

What is the FDA product code for Neuro Omega System; NeuroSmart System?

The FDA product code for Neuro Omega System; NeuroSmart System is GZL.

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Other Devices by Alpha Omega Engineering , Ltd.

K171581Neuro Omega System K172042NeuroNav System, NeuroSmart System K191739Sterile LeadConfirm K220553Neuro 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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