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

    GUNKEL CHROMAGRAPH COLOR VISION TESTER

    K Number: K860174 · Decision Apr 4, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    77

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    Basic Information

    Device Name
    GUNKEL CHROMAGRAPH COLOR VISION TESTER
    K Number
    K860174
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1070
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Chromagraphics, Inc.
    Date Received
    January 17, 1986
    Decision Date
    April 4, 1986
    Product Code
    HIW
    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
    HIW Anomaloscope

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