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

    VIBRATRON II, VIBRATION SENSITIVITY TESTER

    K Number: K863607 · Decision Dec 3, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    12
    Applicant Total
    5
    Review Days
    78

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    Basic Information

    Device Name
    VIBRATRON II, VIBRATION SENSITIVITY TESTER
    K Number
    K863607
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    882.1200
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Sensortek, Inc.
    Date Received
    September 16, 1986
    Decision Date
    December 3, 1986
    Product Code
    LLN
    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
    LLN Device, Vibration Threshold Measurement

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