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510(k) Data Aggregation

    K Number
    K021289
    Device Name
    WARMER 2000LD
    Manufacturer
    O.R. SOLUTIONS, INC.
    Date Cleared
    2002-06-26

    (64 days)

    Product Code
    LHC
    Regulation Number
    890.5950
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    WARMER 2000LD

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

    The ORS-2000LD is designed to warm and maintain the temperature of surgical solutions prior to their use.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is related to a 510(k) clearance letter for the "Warmer 2000LD" device, which is a "Powered Heating Unit" designed to warm and maintain the temperature of surgical solutions.

    However, the document does not contain any information regarding acceptance criteria, device performance metrics, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established.

    The letter is a regulatory document stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It refers to general controls and regulations but does not delve into the specific performance studies that would be required to establish acceptance criteria and device performance.

    Therefore, I cannot provide the requested table and study details based on the given input.

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