BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO

    K Number: K081447 · Decision Oct 8, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    187
    Applicant Total
    10
    Review Days
    139

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    Basic Information

    Device Name
    FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO
    K Number
    K081447
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5160
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Draeger Medical AG & Co. KG
    Date Received
    May 22, 2008
    Decision Date
    October 8, 2008
    Product Code
    BSZ
    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
    BSZ Gas-Machine, Anesthesia

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