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510(k) Data Aggregation

    K Number
    K030468
    Device Name
    ACURA ELITE GRAVITY COMPENSATING RESERVOIR
    Manufacturer
    PHOENIX BIOMEDICAL CORP.
    Date Cleared
    2003-10-15

    (245 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ACURA ELITE GRAVITY COMPENSATING RESERVOIR

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

    This device is intended for implantation over either right or left frontal horn, in conjunction with a ventricles for the purpose of diagnostic studies, therapeutic drug access to the cord/or diversion of cerebrospinal fluid.

    Device Description

    Accura Elite Gravity Compensating Reservoir

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a device called "Acura Elite Gravity Compensating Reservoir." This letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed.

    However, the letter does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth, or an AI algorithm. This document is a regulatory approval letter, not a scientific study report or clinical trial summary.

    Therefore, it is impossible to extract the requested information from the provided text.

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