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

    Digital Blood Pressure Monitor-Automatic Upper Arm Style

    K Number: K163606 · Decision May 9, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    4
    Review Days
    139

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    Basic Information

    Device Name
    Digital Blood Pressure Monitor-Automatic Upper Arm Style
    K Number
    K163606
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Combei Technology Co., Ltd.
    Date Received
    December 21, 2016
    Decision Date
    May 9, 2017
    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 Shenzhen Combei Technology Co., Ltd.

    K Number Device Name
    K202741 Infrared Forehead Thermometer
    K181104 Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style
    K171833 Digital Blood Pressure Monitor-Wrist Style