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Found 8 results
510(k) Data Aggregation
K Number
K023289Device 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
868.5895Why 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
K010793Device Name
OXYLOG 1000, MODEL 2M86840
Manufacturer
DRAGER MEDIZINTECHNIK GMBH
Date Cleared
2001-12-20
(279 days)
Product Code
CBK
Regulation Number
868.5895Why 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
K012177Device Name
VENTVIEW, MODEL 8414095
Manufacturer
DRAGER MEDIZINTECHNIK GMBH
Date Cleared
2001-09-04
(54 days)
Product Code
CBK
Regulation Number
868.5895Why 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
K003068Device Name
SAVINA
Manufacturer
DRAGER MEDIZINTECHNIK GMBH
Date Cleared
2001-06-25
(266 days)
Product Code
CBK
Regulation Number
868.5895Why 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
K010093Device 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
868.5895Why 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
K010724Device Name
SOLA 700,SOLA 500, SOLA 300
Manufacturer
DRAGER MEDIZINTECHNIK GMBH
Date Cleared
2001-06-07
(87 days)
Product Code
FTD
Regulation Number
878.4580Why 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
K003067Device Name
CALEO
Manufacturer
DRAGER MEDIZINTECHNIK GMBH
Date Cleared
2000-12-13
(72 days)
Product Code
FMZ
Regulation Number
880.5400Why 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
K984611Device 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
878.4580Why 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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