BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    OPTYSE OPHTHALMOSCOPE

    K Number: K061278 · Decision May 16, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    46
    Applicant Total
    1
    Review Days
    8

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    Basic Information

    Device Name
    OPTYSE OPHTHALMOSCOPE
    K Number
    K061278
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    886.1570
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ophthalmos , Ltd.
    Date Received
    May 8, 2006
    Decision Date
    May 16, 2006
    Product Code
    HLJ
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    HLJ Ophthalmoscope, Battery-Powered

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