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510(k) Data Aggregation

    K Number
    K092903
    Device Name
    BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING
    Date Cleared
    2009-12-01

    (71 days)

    Product Code
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAQUET GMBH AND CO. KG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bora UP 2080, BORA UP 2080 OP and BORA UP 2080 MOUNTING are intended as extraction suction units for aspiration and removal of fluids, and infectious material from wounds or tissue either during surgery or at the patient's bedside.
    Device Description
    The MEDAP BORA is a high performance, low-noise suction pump designed for continuous operation and suitable for high flow/high vacuum. The vacuum for the MEDAP BORA is produced by an electrically driven pump unit. The pump must be operated with an overflow protection device. The overflow protection device with float prevents the unit from oversuction. In the event of a high filling level, the float rises, closes the suction line and prevents liquid from discharging. In addition, the hydrophobic bacterial and viral filter prevents the penetration of particles and liquid into the suction unit. A bacterial filter paper in the exhaust air area guarantees additional safety for patients and operators. The unit is equipped with a hydrophobic bacterial and viral filter to protect the inside of the pump from bacterial contamination. This hydrophobic bacterial and viral filter must be used when treating infectious patients. The vacuum can be set from 0 to -90kPa (0 to -675 mmHg) using a regulation switch and is controlled using a vacuum gauge.
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