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510(k) Data Aggregation

    K Number
    K100553
    Device Name
    BLOOD PRESSURE METER MODEL CH-101
    Manufacturer
    CITIZEN SYSTEMS JAPAN CO., LTD.
    Date Cleared
    2010-05-25

    (88 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K112273
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Model CH-101 Blood Pressure Meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and is intended to be sold at a retail shop and to be used for checking personal health condition at home, and not primarily under the order or direction of a physician.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) Pre-market Notification letter from the FDA to Citizen Systems Japan Co., LTD, regarding their Citizens Blood Pressure Meter, Model CH-101. It details the substantial equivalence determination and regulatory requirements. However, it does not contain the acceptance criteria or a study proving the device meets said criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with specific acceptance criteria.

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