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510(k) Data Aggregation

    K Number
    K972066
    Device Name
    BELZER-MPS
    Manufacturer
    TRANS-MED CORP.
    Date Cleared
    1997-11-26

    (176 days)

    Product Code
    KDN
    Regulation Number
    876.5880
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRANS-MED CORP.

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

    Belzer~MPS™ is the UW-gluconate perfusion solution indicated for the flushing and continuous hypothermic machine perfusion of donor kidneys.

    Device Description

    Belzer-MPSTM is the UW-gluconate perfusion solution

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the Belzer-MPS™ device. It confirms that the device is substantially equivalent to previously marketed devices for the flushing and continuous hypothermic machine perfusion of donor kidneys.

    However, this document does not contain any information regarding acceptance criteria, device performance results, details of a study (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), or how ground truth was established.

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

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