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510(k) Data Aggregation

    K Number
    K012310
    Device Name
    MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR
    Manufacturer
    HEALTH & LIFE CO., LTD.
    Date Cleared
    2001-08-22

    (30 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K030230
    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 age 16 and above.

    Device Description

    Full Automatic (NIBP) Blood Pressure Monitor

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to complete the table and answer all the questions regarding acceptance criteria, study details, and ground truth establishment for the HL168D Non-Invasive Blood Pressure Monitor. The document is a 510(k) clearance letter from the FDA, which confirms substantial equivalence but does not describe the specific performance studies in detail.

    The letter mentions that the device "Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method." It also states "The intended for use of this over-the-counter device is for age 16 and above." However, it does not provide quantitative acceptance criteria for blood pressure and heart rate measurements, nor does it present the results of specific studies against such criteria.

    Therefore, I cannot provide the requested table and detailed responses based on the input document.

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