Search Filters

Search Results

Found 29 results

510(k) Data Aggregation

    K Number
    K042607
    Device Name
    PRIMUS US
    Manufacturer
    DRAEGER MEDICAL, INC.
    Date Cleared
    2004-11-26

    (63 days)

    Product Code
    BSZ
    Regulation Number
    868.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRAEGER MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Primus US is indicated as a continuous flow anesthesia system. The Primus US may be used for manually assisted, or automatic ventilation, and delivery of gases, anesthetic vapor, and monitoring of; oxygen and CO2 concentration, breathing pressure, respiratory volume, and anesthetic agent identification and concentration. Federal law restricts this device to sale by or on the order of a physician.
    Device Description
    The Primus US, is a continuous flow gas anesthesia system that delivers anesthetic vapor, provides for automatic and manual modes of ventilation, and is equipped with a monitoring system for ventilation, inspired and expired gas, and agent identification.
    Ask a Question
    K Number
    K042419
    Device Name
    FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM
    Manufacturer
    DRAEGER MEDICAL, INC.
    Date Cleared
    2004-10-08

    (31 days)

    Product Code
    BSZ
    Regulation Number
    868.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRAEGER MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fabius GS/Fabius Tiro is indicated as a continuous flow anesthesia system. The Fabius GS/Fabius Tiro can be used for spontaneous, manually assisted, automatic, pressure support, or synchronized mandatory intermittent ventilation, delivery of gases and anesthetic vapor, and monitoring oxygen concentration, breathing pressure and respiratory volume of patients during anesthesia. Federal law restricts this device to sale by or on the order of a physician.
    Device Description
    The Fabius GS/Fabius Tiro is a continuous flow gas anesthesia system.
    Ask a Question
    K Number
    K042276
    Device Name
    D-VAPOR
    Manufacturer
    DRAEGER MEDICAL, INC.
    Date Cleared
    2004-09-23

    (31 days)

    Product Code
    CAD, DEV
    Regulation Number
    868.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRAEGER MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The D-Vapor is an electronic calibrated vaporizer designed to enrich the fresh gas flow of an anesthesia delivery system with a controlled amount of anesthetic vapor. The D-Vapor is intended for use with Desflurane. It is not intended for use with Enflurane, Halothane, Isoflurane, or Sevoflurane or for use in a breathing circuit. Federal law restricts this device to sale by or on the order of a physician.
    Device Description
    The D-Vapor is an electronic calibrated vaporizer designed to enrich the fresh gas flow of an anesthesia delivery system with a controlled amount of Desflurane anesthetic vapor in concentrations of 2 to 18 vol.%.
    Ask a Question
    K Number
    K042086
    Device Name
    FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM
    Manufacturer
    DRAEGER MEDICAL, INC.
    Date Cleared
    2004-08-31

    (28 days)

    Product Code
    BSZ
    Regulation Number
    868.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRAEGER MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fabius GS and Fabius Tiro are indicated as a continuous flow anesthesia systems. The Fabius GS and Fabius Tiro are indicated for spontaneous, manually assisted, automatic or pressure support ventilation; delivery of gases and anesthetic vapor of patients during anesthesia. The Fabius GS and Fabius Tiro can monitor inspired oxygen concentration, breathing pressure and respiratory volume of patients during anesthesia. The Fabius GS and Fabius Tiro are to be used only in the order of a physician.
    Device Description
    The Fabius GS and Fabius Tiro are continuous flow gas anesthesia systems.
    Ask a Question
    K Number
    K041622
    Device Name
    MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM
    Manufacturer
    DRAEGER MEDICAL, INC.
    Date Cleared
    2004-07-08

    (22 days)

    Product Code
    BSZ
    Regulation Number
    868.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRAEGER MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fabius GS is indicated as a continuous flow anesthesia system. The Fabius GS can be used for spontaneous, manually assisted, automatic or pressure support ventilation, delivery of gases and anesthetic vapor, and monitoring oxygen concentration, breathing pressure and respiratory volume of patients during anesthesia. Federal law restricts this device to sale by or on the order of a physician. The Fabius Tiro is indicated as a continuous flow anesthesia system. The Fabius Tiro can be used for spontaneous, manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring oxygen concentration, breathing pressure and respiratory volume of patients during anesthesia. Federal law restricts this device to sale by or on the order of a physician.
    Device Description
    The Fabius GS and Fabius Tiro are continuous flow gas anesthesia systems. The compact breathing system (COSY) used with the Fabius GS (K030624) and Fabius Tiro (K031400) anesthesia systems is being modified to incorporate a heater plate. The addition of a heater plate is a hardware change only. The basic infrastructure, operating principle, alarm strategies, fault detection circuitry, and mechanical/pneumatic subassemblies within the Fabius GS/Tiro remain unchanged. The heater consists of a heater foil, metal plate and insulator plate that are mounted between the absorber canister and COSY block. The heater subassembly is connected via a power cable to a separate power supply mounted externally to a Fabius GS/Tiro Anesthesia System. Like the heater plate utilized in the NM6400's (K033498) Divan ventilator, the heater incorporated into the COSY is intended to warm the breathing system to minimize moisture accumulation in the breathing system components, especially during cases utilizing low flow anesthesia and/or during cases of low ambient environmental temperatures. It is not intended to control or maintain a set temperature of the patient breathing gas or to humidify the gas. Once activated, the heating plate in the COSY, like the NM6400, heats up to a constant temperature. This heat is then transferred, through conduction, to the components of the breathing system above it. In the NM6400, the heater plate is activated when the NM6400 System Power switch is turned to the "On" position and is de-activated when the NM6400 is switched to "Standby." With the COSY, heater activation is independent of the Fabius GS/Tiro. To activate the heater, the user is required to switch the heater power supply to the "On" position. To deactivate, the user is required to switch the power supply to the "Off" position.
    Ask a Question
    K Number
    K040847
    Device Name
    MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR
    Manufacturer
    DRAEGER MEDICAL, INC.
    Date Cleared
    2004-06-17

    (77 days)

    Product Code
    CCK, CBQ, CBR, CBS, DQA, NHO, NHP, NHQ
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRAEGER MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vamos Anesthetic Gas monitor is indicated for measuring and monitoring CO2 concentration, functional oxygen saturation (SPO2), pulse rate and the concentrations of N2O, Halothane, Isoflurane, Enflurane and Desflurane.
    Device Description
    The modified Vamos is an integrated monitoring system used for the multiple gas analysis (CO2), N2O), and anesthetic agent concentrations). Pulse Oximetry may also be included as an option.
    Ask a Question
    K Number
    K033498
    Device Name
    NARKOMED 6400, MODEL NM6400
    Manufacturer
    DRAEGER MEDICAL, INC.
    Date Cleared
    2004-04-26

    (173 days)

    Product Code
    BSZ
    Regulation Number
    868.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRAEGER MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NM6400 w/IPM is indicated as a continuous flow anesthesia system. The NM6400 w/IPM may be used for manually assisted, or automatic ventilation, and delivery of gases, anesthetic vapor, and monitoring of; oxygen concentration, breathing pressure, respiratory volume, cardiovascular parameters, anesthetic agent identification and concentration and provides printed data. Federal law restricts this device to sale by or on the order of a physician.
    Device Description
    The Narkomed 6400 w/ Integrated Patient Monitoring is a continuous flow gas anesthessa system with cardiovascular monitoring.
    Ask a Question
    K Number
    K030624
    Device Name
    MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM
    Manufacturer
    DRAEGER MEDICAL, INC.
    Date Cleared
    2004-03-17

    (384 days)

    Product Code
    BSZ
    Regulation Number
    868.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRAEGER MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fabius GS is indicated as a continuous flow anesthesia system. The Fabius GS can be used for spontaneous, manually assisted, automatic or pressure support ventilation, delivery of gases and ancillaries in patients during anesthesia. Federal law restricts this device to sale by or on the order of a physician.
    Device Description
    The modified Fabius GS is a continuous flow gas anesthesia system.
    Ask a Question
    K Number
    K031400
    Device Name
    FABIUS TIRO ANESTHESIA SYSTEM
    Manufacturer
    DRAEGER MEDICAL, INC.
    Date Cleared
    2003-07-15

    (71 days)

    Product Code
    BSZ
    Regulation Number
    868.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRAEGER MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fabius Tiro is indicated as a continuous flow anesthesia system. The Fabius Tiro can be used for spontaneous, manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring oxygen concentration, breathing pressure and respiratory volume of patients during anesthesia. Federal law restricts this device to sale by or on the order of a physician.
    Device Description
    The modified Fabius GS (Fabius Tiro) is a continuous flow gas anesthesia system.
    Ask a Question
    K Number
    K022031
    Device Name
    NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2
    Manufacturer
    DRAEGER MEDICAL, INC.
    Date Cleared
    2002-08-29

    (69 days)

    Product Code
    BSZ
    Regulation Number
    868.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRAEGER MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NM-MRI-2 can be used for spontaneous, manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring oxygen concentration, breathing pressure and respiratory volume of patients during anesthesia. The NM-MRI-2 is intended for use with Dräger-Vapor® vaporizers. The NM-MRI-2 can be used in MRI scanner rooms with magnet strengths up to 3.0 tesla without distance limitations.
    Device Description
    The Narkomed MRI-2 (NM-MRI-2) is a continuous flow gas anesthesia system.
    Ask a Question

    Page 1 of 3