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510(k) Data Aggregation

    K Number
    K023289
    Device Name
    OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072
    Manufacturer
    DRAGER MEDIZINTECHNIK GMBH
    Date Cleared
    2003-01-15

    (105 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRAGER MEDIZINTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Long-term ventilator for intensive care. For patient requiring tidal volume starting at 50 ml.
    Device Description
    Savina is a long term ventilator unit designed for patients with a tidal volume of 50 ml or more and is used in the intensive care areas, recovery rooms, inter and intra hospital transport and subacute care facilities. NIV means Non-Invasive Ventilation and supports the mask application mode. The NIV Option is available for Savina with SW 2.0. The NIV Option for Savina expands the range of available ventilation strategies to include Non-Invasive Ventilation. NIV is not a new ventilation mode but a different format to deliver ventilation to the patient. With the NIV Option activated, the user can switch the ventilator during preparation of the machine into one of two application modes: a) "Tube" application mode, b) "Mask" application mode. The "Tube" application mode corresponds to the reqular behavior of the device if the NIV option is not activated. If the "Mask" application mode is selected, the user gains the option to configure parts of the device integrated monitoring to adapt the specific need of the mask ventilated patient.
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    K Number
    K010793
    Device Name
    OXYLOG 1000, MODEL 2M86840
    Manufacturer
    DRAGER MEDIZINTECHNIK GMBH
    Date Cleared
    2001-12-20

    (279 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRAGER MEDIZINTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K012177
    Device Name
    VENTVIEW, MODEL 8414095
    Manufacturer
    DRAGER MEDIZINTECHNIK GMBH
    Date Cleared
    2001-09-04

    (54 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRAGER MEDIZINTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VentView - a PC programm for displaying ventilation parameters and status messages in both graphical and numerical form for the Drager ventilators Savina, Evita 2 dura and Evita 4.
    Device Description
    VentView - a PC programm for displaying ventilation parameters and status messages in both graphical and numerical form for the Drager ventilators Savina, Evita 2 dura and Evita 4.
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    K Number
    K003068
    Device Name
    SAVINA
    Manufacturer
    DRAGER MEDIZINTECHNIK GMBH
    Date Cleared
    2001-06-25

    (266 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRAGER MEDIZINTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010093
    Device Name
    NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474
    Manufacturer
    DRAGER MEDIZINTECHNIK GMBH
    Date Cleared
    2001-06-14

    (154 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRAGER MEDIZINTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010724
    Device Name
    SOLA 700,SOLA 500, SOLA 300
    Manufacturer
    DRAGER MEDIZINTECHNIK GMBH
    Date Cleared
    2001-06-07

    (87 days)

    Product Code
    FTD
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRAGER MEDIZINTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003067
    Device Name
    CALEO
    Manufacturer
    DRAGER MEDIZINTECHNIK GMBH
    Date Cleared
    2000-12-13

    (72 days)

    Product Code
    FMZ
    Regulation Number
    880.5400
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRAGER MEDIZINTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K984611
    Device Name
    DRAGER SOLA SERIES, MODELS 1000/700/500/300
    Manufacturer
    DRAGER MEDIZINTECHNIK GMBH
    Date Cleared
    1999-03-29

    (90 days)

    Product Code
    FSY
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRAGER MEDIZINTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Drager Sola surgical lights (Sola 1000, 700, 500) are intended to locally illuninate an operating or examination area of the patient's body with high intensity light. The Drager Sola 300 is intended to be used as an examination light or as a satellite light within a surgical lighting system.
    Device Description
    Not Found
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