BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471

    K Number: K984223 · Decision Apr 28, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    420
    Registration Numbers
    420
    Same Product Code
    1186
    Applicant Total
    8
    Review Days
    154

    Basic Information

    Device Name
    BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471
    K Number
    K984223
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CITIZEN WATCH CO., LTD.
    Date Received
    November 25, 1998
    Decision Date
    April 28, 1999
    Product Code
    DXN
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXN System, Measurement, Blood-Pressure, Non-Invasive

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