BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ADX4000W

    K Number: K134055 · Decision May 9, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    205
    Applicant Total
    5
    Review Days
    129

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    Basic Information

    Device Name
    ADX4000W
    K Number
    K134055
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.1800
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dexcowin Co., Ltd.
    Date Received
    December 31, 2013
    Decision Date
    May 9, 2014
    Product Code
    MUH
    Advisory Committee
    Dental
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MUH System, X-Ray, Extraoral Source, Digital

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    Other Clearances by Dexcowin Co., Ltd.

    K Number Device Name
    K173046 Cocoon Portable Handheld X-Ray System
    K143494 ADX6000 Portable X-Ray System; iRayA6
    K133007 DX3000-L
    K083532 ADX4000-L, DX3000-L