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FDA 510(k)

NEUROPROBES

K-Number: K052527 · 2006-04-12

ApplicantAlpha Omega Engineering , Ltd.
Decision Date2006-04-12
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROPROBES 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 2006-04-12 under 510(k) number K052527. 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 NEUROPROBES?

NEUROPROBES is a medical device that received FDA 510(k) clearance on 2006-04-12. The listed applicant is Alpha Omega Engineering , Ltd.. The 510(k) number is K052527.

When did NEUROPROBES receive FDA 510(k) clearance?

NEUROPROBES received FDA 510(k) clearance on 2006-04-12, under 510(k) number K052527.

Who is the listed applicant for NEUROPROBES?

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 NEUROPROBES?

The FDA product code for NEUROPROBES 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.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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