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

    MODIFIED DEVICE FOR SELF EXAMINATION OF EYES

    K Number: K863429 · Decision Jan 20, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    138

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    Basic Information

    Device Name
    MODIFIED DEVICE FOR SELF EXAMINATION OF EYES
    K Number
    K863429
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1330
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Wheel Checkers
    Date Received
    September 4, 1986
    Decision Date
    January 20, 1987
    Product Code
    HOQ
    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
    HOQ Grid, Amsler

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    Other Clearances by Wheel Checkers

    K Number Device Name
    K843702 APPARATUS & METHODS SELF-EXAM OF EYE