BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    ELLEX SLIT LAMP, MODEL 30XL

    K Number: K063352 · Decision Mar 13, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    55
    Same Product Code
    107
    Applicant Total
    5
    Review Days
    127

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    Basic Information

    Device Name
    ELLEX SLIT LAMP, MODEL 30XL
    K Number
    K063352
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Takagi Seiko Co., Ltd.
    Date Received
    November 6, 2006
    Decision Date
    March 13, 2007
    Product Code
    HJO
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HJO Biomicroscope, Slit-Lamp, Ac-Powered

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