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

    MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR

    K Number: K040847 · Decision Jun 17, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    78
    Review Days
    77

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    Basic Information

    Device Name
    MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR
    K Number
    K040847
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Draeger Medical, Inc.
    Date Received
    April 1, 2004
    Decision Date
    June 17, 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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