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

    ANYRAY PORTABLE X-RAY SYSTEM

    K Number: K081899 · Decision Aug 21, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    189
    Applicant Total
    1
    Review Days
    49

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    Basic Information

    Device Name
    ANYRAY PORTABLE X-RAY SYSTEM
    K Number
    K081899
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1800
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    E-Woo Technology Co., Ltd.
    Date Received
    July 3, 2008
    Decision Date
    August 21, 2008
    Product Code
    EHD
    Advisory Committee
    Dental
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    EHD Unit, X-Ray, Extraoral With Timer

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