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510(k) Data Aggregation

    K Number
    K030499
    Device Name
    HL888HM
    Manufacturer
    HEALTH & LIFE CO., LTD.
    Date Cleared
    2003-04-17

    (57 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. 8.7" to 12.6" ) .

    Device Description

    H&L Full Automatic (NIBP) Blood Pressure Monitor

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a blood pressure monitor, indicating that the device has been found substantially equivalent to a legally marketed predicate device. It specifies the device name, trade name, indications for use, and regulatory information, but it does not detail performance acceptance criteria or the results of a study.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study.

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