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

    PUPILSCAN

    K Number: K854169 · Decision Dec 16, 1985
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    62

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    Basic Information

    Device Name
    PUPILSCAN
    K Number
    K854169
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Applicant
    Fairville Medical Optics, Inc.
    Date Received
    October 15, 1985
    Decision Date
    December 16, 1985
    Advisory Committee
    Unknown
    Review Advisory Committee
    OP
    Third Party
    N