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

    THE INTUITIVE COLORIMETER

    K Number: K012298 · Decision Sep 26, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    68

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    Basic Information

    Device Name
    THE INTUITIVE COLORIMETER
    K Number
    K012298
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1160
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cerium Optical Technologies, Inc.
    Date Received
    July 20, 2001
    Decision Date
    September 26, 2001
    Product Code
    NFD
    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
    NFD Selector, Color, Spectacle, Lens, Tint