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

    KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C

    K Number: K954780 · Decision Dec 1, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    155
    Applicant Total
    10
    Review Days
    45

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    Basic Information

    Device Name
    KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C
    K Number
    K954780
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1120
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kowa Optimed, Inc.
    Date Received
    October 17, 1995
    Decision Date
    December 1, 1995
    Product Code
    HKI
    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
    HKI Camera, Ophthalmic, Ac-Powered

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