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510(k) Data Aggregation

    K Number
    K062267
    Device Name
    OXYLOG 3000
    Manufacturer
    DRAGER MEDICAL B.V.
    Date Cleared
    2006-10-31

    (88 days)

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

    DRAGER MEDICAL B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Oxylog 3000 is a time-cycled, volume-constant and pressure controlled emergency and transport ventilator for patients with a tidal volume from 50 mL upwards.
    Device Description
    The Oxylog 3000 is a time-cycled, volume-constant and pressure controlled emergency and transport ventilator for patients with a tidal volume from 50 mL upwards. The device is intended for use by trained healthcare professionals, i.e. doctors, nurses, technicians, respiratory therapists, paramedics. The device is intended for mobile use for emergency medical care or primary care of emergency patients: - During transport in emergency rescue vehicles or aircrafts including helicopters . . In accident and emergency departments, in the recovery room. Mobile use for secondary transfers: - During transfer by road or air ' - l When moving ventilated patients around in the hospital.
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