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

    EMG - ESSENTIAL GAS MODULE, MODEL M1013A

    K Number: K041956 · Decision Aug 9, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    2
    Review Days
    19

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    Basic Information

    Device Name
    EMG - ESSENTIAL GAS MODULE, MODEL M1013A
    K Number
    K041956
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Draeget Medical AG & Co. Kgaa
    Date Received
    July 21, 2004
    Decision Date
    August 9, 2004
    Product Code
    CCK
    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
    CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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