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

    CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS

    K Number: K081743 · Decision Sep 22, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    10
    Review Days
    95

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    Basic Information

    Device Name
    CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS
    K Number
    K081743
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Draeger Medical AG & Co. KG
    Date Received
    June 19, 2008
    Decision Date
    September 22, 2008
    Product Code
    CBK
    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
    CBK Ventilator, Continuous, Facility Use

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    K083050 EVITE XL
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    K072885 CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110
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