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510(k) Data Aggregation

    K Number
    K993432
    Device Name
    ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46
    Manufacturer
    ROSSMAX INTERNATIONAL LTD.
    Date Cleared
    1999-12-20

    (69 days)

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

    To measure systolic and diastolic blood pressure and heart rate on the wrist using the oscillometric method. Limited to patient over 18 years and wrist circumference between 5.3 to 7.7 inches.

    Device Description

    Rossmax Automatic Wristwatch Blood Pressure Monitor, model Z46

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA letter granting substantial equivalence for a blood pressure monitor, focusing on regulatory aspects rather than detailed study results. Therefore, I cannot generate the requested table and information.

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