BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    60 FUNDUS CAMERA CF-60UV

    K Number: K901839 · Decision Jul 5, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    7
    Applicant Total
    48
    Review Days
    72

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    Basic Information

    Device Name
    60 FUNDUS CAMERA CF-60UV
    K Number
    K901839
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1395
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Canon USA, Inc.
    Date Received
    April 24, 1990
    Decision Date
    July 5, 1990
    Product Code
    HJI
    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
    HJI Lens, Fundus, Hruby, Diagnostic

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