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510(k) Data Aggregation

    K Number
    K032695
    Device Name
    HL888BF
    Manufacturer
    HEALTH & LIFE CO., LTD.
    Date Cleared
    2003-10-02

    (30 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 adult patients whose arm circumference between 24-32cm (approx. 9.4" to 12.6" ) .

    Device Description

    H&L Full Automatic (NIBP) Blood Pressure Monitor, Trade Name : HL888BF. 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.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a non-invasive blood pressure measurement system (HL888BF). It does not contain any information regarding acceptance criteria, study details, or performance data for the device.

    Therefore, I cannot extract the requested information. The letter only confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

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