Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Alpha Omega Engineering , Ltd.. It received FDA 510(k) clearance on 2025-03-30 under 510(k) 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. The listed applicant is Alpha Omega Engineering , Ltd.. The 510(k) number is K250601.

When did Neuro Omega System; NeuroSmart System receive FDA 510(k) clearance?

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

Who is the listed applicant for Neuro Omega System; NeuroSmart System?

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

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

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

Other records listing Alpha Omega Engineering , 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.

K220553Neuro Omega System, NeuroSmart SystemK191739Sterile LeadConfirmK172042NeuroNav System, NeuroSmart SystemK171581Neuro Omega System

Related Devices (Code: GZL)

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.

K253970Wovyn Depth ElectrodeSensomedical Labs, Ltd.K250363Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); DeptBeijing Sinovation Medical Technology Co., Ltd.K223276Anchor Bolts as Accessories to Depth ElectrodesAd-Tech Medical Instrument CorporationK223269Spencer Probe Depth ElectrodesAd-Tech Medical Instrument CorporationK213170SENSOSEEG Depth ElectrodesSensomedical Labs, Ltd.K222706iCE-SG2 Subcutaneous Electrode KitIce Neurosystems, Inc.

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.

↑