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

    EASYSCAN MODEL 1.2

    K Number: K111988 · Decision Oct 28, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    14
    Same Product Code
    21
    Applicant Total
    1
    Review Days
    107

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    Basic Information

    Device Name
    EASYSCAN MODEL 1.2
    K Number
    K111988
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1570
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    I-Optics BV
    Date Received
    July 13, 2011
    Decision Date
    October 28, 2011
    Product Code
    MYC
    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
    MYC Ophthalmoscope, Laser, Scanning

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