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510(k) Data Aggregation

    K Number
    K042137
    Device Name
    PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS
    Manufacturer
    PROMEDICAL PRODUCTS CO., LTD.
    Date Cleared
    2004-10-05

    (57 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS

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

    proMedical Products Co. Ltd. intends to market Non-sterile surgical equipment covers which are protective barrier covers that are intended to cover equipment and provide a protective barrier for that equipment.

    Device Description

    Non-sterile surgical equipment covers which are protective barrier covers that are intended to cover equipment and provide a protective barrier for that equipment.

    AI/ML Overview

    The provided text is a clearance letter from the FDA for a medical device called "ProMedical Surgical Equipment Covers". It does not contain information about acceptance criteria or a study proving device performance in the way a diagnostic AI/ML device submission would.

    The document pertains to a Class II device (Surgical Drape and Drape Accessories) which is a physical product designed to provide a protective barrier for surgical equipment. The FDA clearance is based on "substantial equivalence" to legally marketed predicate devices, not on a performance study against specific acceptance criteria.

    Therefore, I cannot provide the requested information from this document. The questions you've asked are typically relevant for AI/ML-driven diagnostic devices that undergo rigorous performance evaluation studies, which is not the case for this type of surgical equipment cover.

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