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510(k) Data Aggregation

    K Number
    K050083
    Device Name
    BLOOD-PRESSURE METER, BPW120
    Manufacturer
    IDT TECHNOLOGY LIMITED
    Date Cleared
    2005-04-08

    (85 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K131026
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    By using oscillometric method, measures automatically human's Systolic, Diastolic, mean blood pressure, and heart rate. All values will be read out in LCD panel.

    Device Description

    Blood-pressure meter, Model BPW120

    AI/ML Overview

    The provided document is a 510(k) premarket notification approval letter for a blood pressure meter. It does not contain information about acceptance criteria, study details, or ground truth for an AI/ML device. Therefore, I cannot extract the requested information from this document.

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