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

    NIBPCuff

    K Number: K231961 · Decision Aug 30, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    197
    Applicant Total
    3
    Review Days
    58

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    Basic Information

    Device Name
    NIBPCuff
    K Number
    K231961
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Sino-K Medical Technology Co.,Ltd
    Date Received
    July 3, 2023
    Decision Date
    August 30, 2023
    Product Code
    DXQ
    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
    DXQ Blood Pressure Cuff

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