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510(k) Data Aggregation

    K Number
    K020766
    Device Name
    HL168F
    Manufacturer
    HEALTH & LIFE CO., LTD.
    Date Cleared
    2002-04-05

    (28 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

    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

    The provided document is an FDA 510(k) clearance letter for a non-invasive blood pressure measurement system (HL168F). It confirms the device's substantial equivalence to a predicate device but does not contain the detailed acceptance criteria or the study that proves the device meets those criteria.

    The document primarily focuses on regulatory approval and mentions the device's intended use and classification. It does not provide information about performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.

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

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