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510(k) Data Aggregation

    K Number
    K032837
    Device Name
    HL888BM
    Manufacturer
    HEALTH & LIFE CO., LTD.
    Date Cleared
    2003-10-10

    (29 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K093823
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Manual inflate type blood pressure monitor for measurement of 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 use of this over-the counter device is for adult patients whose arm circumference is between 24-32cm (approx. 9.4" to 12.6").

    Device Description

    H&L Full Automatic (NIBP) Blood Pressure Monitor, Trade Name : HL888BM

    AI/ML Overview

    I'm sorry, but without further documentation in your provided text beyond this 510(k) summary, I am unable to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the only thing provided is a letter from the FDA regarding a particular device. This letter does not contain information on acceptance criteria, device performance, study details, ground truth establishment, or training set specifics.

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