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

    ELECTRONIC DIGITAL BLOOD PRESSURE/PULSE MONITOR

    K Number: K911965 · Decision Oct 28, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    8
    Review Days
    179

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    Basic Information

    Device Name
    ELECTRONIC DIGITAL BLOOD PRESSURE/PULSE MONITOR
    K Number
    K911965
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Citizen Watch Co., Ltd.
    Date Received
    May 2, 1991
    Decision Date
    October 28, 1991
    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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    Other Clearances by Citizen Watch Co., Ltd.

    K Number Device Name
    K061161 BLOOD PRESSURE METER, MODEL CH-311B
    K052046 BLOOD PRESSURE METER, MODEL CH-432
    K001244 BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D
    K984223 BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471
    K973061 CH-601A AND CH-601B DIGITAL WRIST SPHYGMOMANOMETER (CH-601A/CH-601B)
    K954547 CH-502A & CH520B DIGITAL FINGER SPHYGMOMANOMETER
    K923344 ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR