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510(k) Data Aggregation

    K Number
    K050714
    Device Name
    FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168GA, HL168GS
    Manufacturer
    HEALTH & LIFE CO., LTD.
    Date Cleared
    2005-04-07

    (20 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K112320
    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 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 a letter from the FDA regarding the 510(k) premarket notification for the HL168GA and HL168GS Full Automatic Pressure Monitor. It confirms the device's substantial equivalence to legally marketed predicate devices. However, it does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, expert involvement, adjudication), or MRMC studies.

    Therefore, I cannot provide the requested information based on the given text.

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