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510(k) Data Aggregation

    K Number
    K042265
    Device Name
    FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR MODEL# HL888
    Manufacturer
    HEALTH & LIFE CO., LTD.
    Date Cleared
    2004-08-31

    (8 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K042203
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD panel. The intended for use of this over-the-counter device is for adult patients with arm circumference between 24cm -- 44cm (approx. 9.4" to 17.5" ) .

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) summary for a blood pressure monitor. It does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria in the format requested.

    The document primarily focuses on the FDA's decision regarding the substantial equivalence of the "Full Automatic (NIBP) Blood Pressure Monitor, Model HL888" to legally marketed predicate devices. It lists the trade name, regulation number, regulatory class, and product code. It also includes the intended use for the device.

    Therefore, I cannot extract the requested information from the provided text.

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