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

    Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11)

    K Number: K221040 · Decision Aug 31, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    2
    Review Days
    146

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    Basic Information

    Device Name
    Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11)
    K Number
    K221040
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jiangxi Aicare Medical Technology Co., Ltd.
    Date Received
    April 7, 2022
    Decision Date
    August 31, 2022
    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 Jiangxi Aicare Medical Technology Co., Ltd.

    K Number Device Name
    K250185 Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24)