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510(k) Data Aggregation

    K Number
    K012265
    Device Name
    METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088
    Manufacturer
    CIRCON VIDEO
    Date Cleared
    2001-10-17

    (90 days)

    Product Code
    FCW,FCR,FFS,GCT
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088

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

    The intended use for the Metal Halide Light Sources is to provide optimized light for viewing procedures carried out with flexible and rigid endoscopes.

    Device Description

    Metal Halide Light Sources Models, MV-9088-T and MV-9088

    AI/ML Overview

    The provided document is a 510(k) premarket notification approval letter for a medical device: "Metal Halide Light Sources Models, MV-9088-T and MV-9088." This letter states that the FDA has determined the device to be substantially equivalent to legally marketed predicate devices.

    However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies. It is a regulatory approval letter based on substantial equivalence, not a detailed study report.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details.

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