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

    VIDEO EYE TRAKKER

    K Number: K964646 · Decision Jul 15, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    58
    Applicant Total
    5
    Review Days
    237

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    Basic Information

    Device Name
    VIDEO EYE TRAKKER
    K Number
    K964646
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1460
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Micromedical Technologies, Inc.
    Date Received
    November 20, 1996
    Decision Date
    July 15, 1997
    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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    Other Clearances by Micromedical Technologies, Inc.

    K Number Device Name
    K964325 VISUALEYES: VIDEO EYE MONITOR
    K922037 SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR
    K891008 VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ)
    K863424 COMPUTER EYE TRACKING SYS./ENG EXAM. CHAIR & TABLE