BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR

    K Number: K121355 · Decision Jul 18, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    14
    Review Days
    75

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    Basic Information

    Device Name
    WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
    K Number
    K121355
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sejoy Electronics & Instruments Co., Ltd.
    Date Received
    May 4, 2012
    Decision Date
    July 18, 2012
    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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    K141755 ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
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    K110776 DIGITAL THERMOMETER MT SERIES
    K082192 INFRARED EAR THERMOMETER, MODEL ET-101A
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