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

    Med-link Reusable Blood Pressure Cuff

    K Number: K173869 · Decision Aug 2, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    197
    Applicant Total
    14
    Review Days
    225

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    Basic Information

    Device Name
    Med-link Reusable Blood Pressure Cuff
    K Number
    K173869
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Med-Link Electronics Tech Co., Ltd.
    Date Received
    December 20, 2017
    Decision Date
    August 2, 2018
    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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    Other Clearances by Shenzhen Med-Link Electronics Tech Co., Ltd.

    K Number Device Name
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