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

    Venera 508 Deep Vein Thrombosis (DVT) Prevention System

    K Number: K180389 · Decision Jun 29, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    4
    Review Days
    136

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    Basic Information

    Device Name
    Venera 508 Deep Vein Thrombosis (DVT) Prevention System
    K Number
    K180389
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Suzhou Minhua Medical Apparatus Supplies Co., Ltd.
    Date Received
    February 13, 2018
    Decision Date
    June 29, 2018
    Product Code
    JOW
    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
    JOW Sleeve, Limb, Compressible

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    Other Clearances by Suzhou Minhua Medical Apparatus Supplies Co., Ltd.

    K Number Device Name
    K241096 Venera 608 Deep Vein Thrombosis (DVT) Prevention System
    K233276 Reusable Blood Pressure Cuff
    K171889 Reusable Blood Pressure Cuff