BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇹 Austria

    ILWAIT TIMER OCULOPRESSOR

    K Number: K112952 · Decision May 10, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    218

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    Basic Information

    Device Name
    ILWAIT TIMER OCULOPRESSOR
    K Number
    K112952
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4610
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Oryx Medical Pty, Ltd.
    Date Received
    October 5, 2011
    Decision Date
    May 10, 2012
    Product Code
    LCC
    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
    LCC Applicator, Ocular Pressure

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