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

    CONFOCAL MICROSCOPE

    K Number: K970414 · Decision Jul 15, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    55
    Same Product Code
    107
    Applicant Total
    1
    Review Days
    173

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    Basic Information

    Device Name
    CONFOCAL MICROSCOPE
    K Number
    K970414
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Con-S , Ltd.
    Date Received
    January 23, 1997
    Decision Date
    July 15, 1997
    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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