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FDA 510(k)

NEURO OMEGA SYSTEM

K-Number: K123796 · 2013-04-05

ApplicantAlpha Omega Engineering , Ltd.
Decision Date2013-04-05
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEURO OMEGA 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 2013-04-05 under 510(k) number K123796. 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 2013-04-05. The listed applicant is Alpha Omega Engineering , Ltd.. The 510(k) number is K123796.

When did NEURO OMEGA SYSTEM receive FDA 510(k) clearance?

NEURO OMEGA SYSTEM received FDA 510(k) clearance on 2013-04-05, under 510(k) number K123796.

Who is the listed applicant for NEURO OMEGA 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?

The FDA product code for NEURO OMEGA SYSTEM is GZL.

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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.

K250601Neuro Omega System; NeuroSmart SystemK220553Neuro Omega System, NeuroSmart SystemK191739Sterile LeadConfirmK172042NeuroNav System, NeuroSmart SystemK171581Neuro Omega SystemK120098STERILE DISPOSABLES FOR MER

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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.K250601Neuro Omega System; NeuroSmart SystemAlpha Omega Engineering , Ltd.K223269Spencer Probe Depth ElectrodesAd-Tech Medical Instrument CorporationK223276Anchor Bolts as Accessories to Depth ElectrodesAd-Tech Medical Instrument CorporationK213170SENSOSEEG Depth ElectrodesSensomedical Labs, Ltd.

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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