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510(k) Data Aggregation

    K Number
    K171282
    Device Name
    Fully Automatic Blood Pressure Monitor
    Manufacturer
    Andon Health Co., Ltd
    Date Cleared
    2017-07-27

    (87 days)

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

    KD-7923 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a noninvasive blood pressure measurement system intended to measure the diastolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 14cm-25cm

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) clearance letter for a blood pressure monitor, not a study report for an AI device. As such, it does not contain the detailed information about acceptance criteria, study methodologies, or AI performance metrics requested.

    Therefore, I cannot provide the requested information. The document is a regulatory approval, not a scientific study describing device performance against specific criteria in the way you've outlined for an AI system.

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