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FDA 510(k)

STERILE DISPOSABLES FOR MER

K-Number: K120098 · 2012-06-12

ApplicantAlpha Omega Engineering , Ltd.
Decision Date2012-06-12
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STERILE DISPOSABLES FOR MER 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 2012-06-12 under 510(k) number K120098. 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 STERILE DISPOSABLES FOR MER?

STERILE DISPOSABLES FOR MER is a medical device that received FDA 510(k) clearance on 2012-06-12. The listed applicant is Alpha Omega Engineering , Ltd.. The 510(k) number is K120098.

When did STERILE DISPOSABLES FOR MER receive FDA 510(k) clearance?

STERILE DISPOSABLES FOR MER received FDA 510(k) clearance on 2012-06-12, under 510(k) number K120098.

Who is the listed applicant for STERILE DISPOSABLES FOR MER?

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 STERILE DISPOSABLES FOR MER?

The FDA product code for STERILE DISPOSABLES FOR MER 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 SystemK123796NEURO OMEGA SYSTEM

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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.K223276Anchor Bolts as Accessories to Depth ElectrodesAd-Tech Medical Instrument CorporationK223269Spencer Probe 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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