BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    COMPUTER EYE TRACKING SYS./ENG EXAM. CHAIR & TABLE

    K Number: K863424 · Decision Mar 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    58
    Applicant Total
    5
    Review Days
    200

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    Basic Information

    Device Name
    COMPUTER EYE TRACKING SYS./ENG EXAM. CHAIR & TABLE
    K Number
    K863424
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1460
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Micromedical Technologies, Inc.
    Date Received
    September 4, 1986
    Decision Date
    March 23, 1987
    Product Code
    GWN
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GWN Nystagmograph

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