BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    PRESS DUO elite, PRESS DUO elite AG

    K Number: K173450 · Decision Feb 7, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    8
    Review Days
    93

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    Basic Information

    Device Name
    PRESS DUO elite, PRESS DUO elite AG
    K Number
    K173450
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nemoto Kyorindo Co., Ltd.
    Date Received
    November 6, 2017
    Decision Date
    February 7, 2018
    Product Code
    DXT
    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
    DXT Injector And Syringe, Angiographic

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