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510(k) Data Aggregation

    K Number
    K033043
    Device Name
    MODIFICATION TO HL168
    Manufacturer
    HEALTH & LIFE CO., LTD.
    Date Cleared
    2003-10-10

    (11 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 uping the oscillometric method. All values can be read out in one LCD Panel.
    The intended use of this over-the counter device is for age 16 and above,

    Device Description

    H&L Full Automatic (NIBP) Blood Pressure Monitor

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a non-invasive blood pressure measurement system (HL168N) and does not contain the acceptance criteria or a study describing device performance.

    Therefore, I cannot provide the requested information. The letter only confirms that the device has been found substantially equivalent to a legally marketed predicate device.

    To get the information you requested, you would typically need to refer to the 510(k) submission itself (which often includes performance data and acceptance criteria) or a separate technical report/study for the device.

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