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

    IN-HOME VISION MONITORING KIT

    K Number: K854047 · Decision Dec 13, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    107
    Same Product Code
    31
    Applicant Total
    1
    Review Days
    71

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    Basic Information

    Device Name
    IN-HOME VISION MONITORING KIT
    K Number
    K854047
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1150
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Rich-Larky Company, Inc.
    Date Received
    October 3, 1985
    Decision Date
    December 13, 1985
    Product Code
    HOX
    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
    HOX Chart, Visual Acuity

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