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

    ICP MONITOR MODEL 1000

    K Number: K844566 · Decision Aug 16, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    104
    Applicant Total
    1
    Review Days
    266

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    Basic Information

    Device Name
    ICP MONITOR MODEL 1000
    K Number
    K844566
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1620
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Advanced Ultrasonic Testing & Research Corp.
    Date Received
    November 23, 1984
    Decision Date
    August 16, 1985
    Product Code
    GWM
    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
    GWM Device, Monitoring, Intracranial Pressure

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