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

    CENTRAL VISION ANALYZER MODEL 1000

    K Number: K100095 · Decision May 10, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    107
    Same Product Code
    31
    Applicant Total
    1
    Review Days
    117

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    Basic Information

    Device Name
    CENTRAL VISION ANALYZER MODEL 1000
    K Number
    K100095
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    886.1150
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vimetrics,Llc.
    Date Received
    January 13, 2010
    Decision Date
    May 10, 2010
    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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