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

    ACTILLUME

    K Number: K894044 · Decision Dec 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    186
    Applicant Total
    2
    Review Days
    198

    Basic Information

    Device Name
    ACTILLUME
    K Number
    K894044
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    AMBULATORY MONITORING, INC.
    Date Received
    June 7, 1989
    Decision Date
    December 22, 1989
    Product Code
    GWQ
    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
    GWQ Full-Montage Standard Electroencephalograph

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    Other Clearances by AMBULATORY MONITORING, INC.

    K Number Device Name
    K854030 WRIST ACTIGRAPH