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510(k) Data Aggregation

    K Number
    K014122
    Device Name
    HL168E
    Manufacturer
    HEALTH & LIFE CO., LTD.
    Date Cleared
    2002-01-16

    (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 age 16 and above.

    Device Description

    Full Automatic (NIBP) Blood Pressure Monitor

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA and does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets them. This document is a clearance letter for a 510(k) premarket notification, indicating that the device has been found substantially equivalent to a predicate device. It does not include the specifics of the performance studies or the acceptance criteria used in those studies.

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