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510(k) Data Aggregation

    K Number
    K051830
    Device Name
    NEURODRIVE SYSTEM
    Manufacturer
    ALPHA OMEGA LTD.
    Date Cleared
    2005-09-16

    (72 days)

    Product Code
    GZL
    Regulation Number
    882.1330
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NEURODRIVE SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Alpha Omega NeuroDrive system is intended to be used to Assist neurosurgeons in the operating room during functional neurosurgery and to aid in the placement of depth electrode.

    Device Description

    NeuroDrive system

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA regarding the Alpha Omega NeuroDrive system. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. This type of FDA letter confirms substantial equivalence to a predicate device, which allows the company to market it. It does not typically include detailed study results, sample sizes, or ground truth methodologies that would be found in a clinical trial report or a scientific publication.

    Therefore, I cannot provide the requested information from this document.

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