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510(k) Data Aggregation
K Number
K082600Device Name
OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082)
Manufacturer
DRAEGER MEDICAL B.V.
Date Cleared
2008-11-26
(79 days)
Product Code
CBK
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
DRAEGER MEDICAL B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Oxylog 2000 plus is a time-cycled, volume controlled emergency and transport ventilator with pressure support for patients requiring mandatory or assisted ventilation with a tidal volume from 100 mL upwards.
Device Description
The Oxylog 2000 p/us is a time-cycled, volume controlled emergency and transport ventilator with pressure support for patients requiring mandatory or assisted ventilation with a tidal volume from 100 ml. upwards. The device is intended for use by and under the supervision of trained healthcare professionals. The device is intended for use in the following environments:
- Mobile use for emergency patients, in both outdoor and indoor environments;
- During transport in ambulances or aircraft, including helicopters;
- In accident and emergency departments;
- When moving ventilated patients around the hospital;
- In the recovery room.
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K Number
K060705Device Name
CARINA HOME
Manufacturer
DRAEGER MEDICAL B.V.
Date Cleared
2006-06-14
(90 days)
Product Code
CBK
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
DRAEGER MEDICAL B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
the Carina home is a pressure controlled and volume controlled (pressure regulated) ventilator. The device is intended for use with patients with a tidal volume of 100 mL upwards. It is used for patients with respiratory insufficiency, using room air (also with additional oxygen). Federal law restricts this device to sale by or on the order of a physician.
Device Description
the Carina home is a pressure controlled and volume controlled (pressure regulated) ventilator. The device is intended for use with patients with a tidal volume of 100 mL upwards. It is used for patients with respiratory insufficiency, using room air (also with additional oxygen).
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