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510(k) Data Aggregation

    K Number
    K012636
    Device Name
    BPTRU AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100
    Manufacturer
    VSM TECHNOLOGY, INC.
    Date Cleared
    2001-10-26

    (74 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K023055,K023078,K061073
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BpTRU:

    • Measures systolic and diastolic blood pressure and pulse rate in subjects 3 years of . age or older.
    • age of officials' offices, nursing units, and patient care areas of ● hospitals.
    Device Description

    Not Found

    AI/ML Overview

    The provided text is a letter from the FDA regarding a 510(k) premarket notification for the BpTRU Automated Non-Invasive Blood Pressure Monitor. It determines substantial equivalence to a predicate device and allows the device to be marketed.

    However, the document does not contain any information about acceptance criteria, study details, device performance data, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

    Therefore, I cannot provide the requested table and study details based on the given input. The information necessary to answer the prompt is not present in the provided FDA letter.

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