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510(k) Data Aggregation

    K Number
    K992090
    Device Name
    MILLENNIUM GOLD
    Manufacturer
    SKYTRON, DIV. THE KMW GROUP, INC.
    Date Cleared
    1999-09-08

    (79 days)

    Product Code
    FSY
    Regulation Number
    878.4580
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K942080
    Why did this record match?
    Device Name :

    MILLENNIUM GOLD

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

    The Millennium Gold Series Surgical light is intended to be used by medical personnel for the purpose of illuminating surgical sites.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Millennium Gold Series Surgical Light. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. It is a regulatory clearance, not a scientific study report.

    Therefore, I cannot provide the requested information based on this input.

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