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

    NEUROMUSCULAR TRANSMISSION MONITOR

    K Number: K840108 · Decision Feb 17, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    28
    Applicant Total
    55
    Review Days
    38

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    Basic Information

    Device Name
    NEUROMUSCULAR TRANSMISSION MONITOR
    K Number
    K840108
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2775
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Datex Division Instrumentarium Corp.
    Date Received
    January 10, 1984
    Decision Date
    February 17, 1984
    Product Code
    KOI
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KOI Stimulator, Nerve, Peripheral, Electric

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