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Found 29 results
510(k) Data Aggregation
K Number
K042607Device Name
PRIMUS US
Manufacturer
DRAEGER MEDICAL, INC.
Date Cleared
2004-11-26
(63 days)
Product Code
BSZ
Regulation Number
868.5160Why 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.
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K Number
K042419Device Name
FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM
Manufacturer
DRAEGER MEDICAL, INC.
Date Cleared
2004-10-08
(31 days)
Product Code
BSZ
Regulation Number
868.5160Why 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.
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K Number
K042276Device Name
D-VAPOR
Manufacturer
DRAEGER MEDICAL, INC.
Date Cleared
2004-09-23
(31 days)
Product Code
CAD, DEV
Regulation Number
868.5880Why 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.%.
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K Number
K042086Device 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
868.5160Why 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.
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K Number
K041622Device 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
868.5160Why 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.
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K Number
K040847Device 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
868.1400Why 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.
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K Number
K033498Device Name
NARKOMED 6400, MODEL NM6400
Manufacturer
DRAEGER MEDICAL, INC.
Date Cleared
2004-04-26
(173 days)
Product Code
BSZ
Regulation Number
868.5160Why 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.
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K Number
K030624Device Name
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM
Manufacturer
DRAEGER MEDICAL, INC.
Date Cleared
2004-03-17
(384 days)
Product Code
BSZ
Regulation Number
868.5160Why 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.
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K Number
K031400Device Name
FABIUS TIRO ANESTHESIA SYSTEM
Manufacturer
DRAEGER MEDICAL, INC.
Date Cleared
2003-07-15
(71 days)
Product Code
BSZ
Regulation Number
868.5160Why 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.
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K Number
K022031Device 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
868.5160Why 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.
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