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

    GLAUCOMA-SCOPE

    K Number: K913118 · Decision Oct 9, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    86
    Applicant Total
    5
    Review Days
    86

    Basic Information

    Device Name
    GLAUCOMA-SCOPE
    K Number
    K913118
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1570
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    OPHTHALMIC IMAGING SYSTEMS
    Date Received
    July 15, 1991
    Decision Date
    October 9, 1991
    Product Code
    HLI
    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
    HLI Ophthalmoscope, Ac-Powered

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