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510(k) Data Aggregation

    K Number
    K041956
    Device Name
    EMG - ESSENTIAL GAS MODULE, MODEL M1013A
    Manufacturer
    DRAEGET MEDICAL AG & CO. KGAA
    Date Cleared
    2004-08-09

    (19 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    **DRAEGET MEDICAL AG **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EGM gas monitor is indicated for measuring and monitoring CO2 concentration and the concentrations of N2O, O2, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane. Federal Law restricts this device to sale by or on the order of a physician.
    Device Description
    The M1013A Essential Gas Module provides a nondispersive infrared measurement of respiratory and anesthetic gases and a paramagnetic measurement of oxygen (Fast O2). It is designed to work with the Philips IntelliVue MP20/30/40/50/60/70/90 Anesthesia option #H30 through a digital interface (RS232). It is intended for measuring the airway gases of #1100 through a dignal interrace (1020) maintenance of, and emergence from anesthesia. The module produces display waves for O2, CO2, N2O, and anesthetic agents, together with The module produces display waves for O2, CO2, N2O, anesthetic agents, and airway respiration rate. An anesthetic agent must be selected manually for measurement. An automatic zero calibration is performed by the Essential Gas Module as required to maintain measurement accuracy.
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    K Number
    K040642
    Device Name
    LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA
    Manufacturer
    DRAEGET MEDICAL AG & CO. KGAA
    Date Cleared
    2004-06-02

    (83 days)

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

    **DRAEGET MEDICAL AG **& CO

    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. Savina is used in intensive care units, recovery rooms, inter and intra hospital transport and subacute care facilities. LPO means Low-Pressure-Oxygen and allows the supply of oxygen from a low pressure source (such as an oxygen concentrator), independently of high pressure O2 sources. The external low pressure oxygen source is to be provided by the user. The LPO option does not affect the ventilation performance. The only difference between HPO and LPO mode is the supply and monitoring of the O2 concentration. The LPO Option is available for Savina with SW 3.n.
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