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

    OPTEC 1000 DMV

    K Number: K863509 · Decision Nov 10, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    107
    Same Product Code
    31
    Applicant Total
    5
    Review Days
    62

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    Basic Information

    Device Name
    OPTEC 1000 DMV
    K Number
    K863509
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1150
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Stereo Optical Co., Inc.
    Date Received
    September 9, 1986
    Decision Date
    November 10, 1986
    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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    Other Clearances by Stereo Optical Co., Inc.

    K Number Device Name
    K924741 OPTEC 3000
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