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FDA 510(k)

NEURODRIVE SYSTEM

K-Number: K051830 · 2005-09-16

ApplicantAlpha Omega , Ltd.
Decision Date2005-09-16
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEURODRIVE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alpha Omega , Ltd.. It received FDA 510(k) clearance on 2005-09-16 under 510(k) number K051830. 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 NEURODRIVE SYSTEM?

NEURODRIVE SYSTEM is a medical device that received FDA 510(k) clearance on 2005-09-16. The listed applicant is Alpha Omega , Ltd.. The 510(k) number is K051830.

When did NEURODRIVE SYSTEM receive FDA 510(k) clearance?

NEURODRIVE SYSTEM received FDA 510(k) clearance on 2005-09-16, under 510(k) number K051830.

Who is the listed applicant for NEURODRIVE SYSTEM?

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

What is the FDA product code for NEURODRIVE SYSTEM?

The FDA product code for NEURODRIVE SYSTEM is GZL.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Alpha Omega , 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.

K071697NEURONAV SYSTEM AND NEURONAV DRIVEK013396ALPHA DRIVE SYSTEMK993622NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY

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

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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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