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510(k) Data Aggregation

    K Number
    K111730
    Device Name
    SONOTT FLOWLAB(R)
    Manufacturer
    Date Cleared
    2012-01-06

    (200 days)

    Product Code
    Regulation Number
    870.2100
    Why did this record match?
    Applicant Name (Manufacturer) :

    EM-TEC GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SonoTT FlowLab® with the accessories is a system to measure the flow rate of liquids (e.g. blood) with the ultrasonic transit-time and velocity patterns of blood with Doppler method. It supports the planning, implementation, efficiency control and documentation of interventions carried out in the area of cardiovascular, vascular and, transplantation, or the monitoring of extracorporeal circulatory systems. The following medical applications are supported: - Intraoperative blood flow measurement with the SonoTT Vascular Probe to assist e surgeons at surgical interventions - Measurement of flow direction and velocities of blood in vessels using the SonoTT Pulse . Wave Doppler Probe to assist the surgeon in the non-invasive assessment of vascular changes. - Extracorporeal flow measurement in continuous operation on tube systems in . combination with the SonoTT Clamp-On Transducer in intensive care units and operating theatres The following actions can be performed simultaneously when these measurements are in progress: - Pressure measurement in combination with a standard blood pressure transducer t - Secondary displays of additional physiological analogue signals and corresponding . derived parameters The SonoTT Vascular Probe is intended for transient use only with continuous contact with patient of less than 60 minutes.
    Device Description
    The SonoTT FlowLab® is used for the volumetric measurement of liquid flowing through tubing systems (in combination with the SonoTT Clamp-On Transducer), to measure blood volume flow (in combination with the SonoTT Vascular Probe) and flow velocity in arteries and veins (in combination with the SonoTT Pulse Wave Doppler Probe). The measurement principle is the ultrasound transit-time and Doppler method.
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    K Number
    K080704
    Device Name
    LOW FLUID ALARM
    Manufacturer
    Date Cleared
    2008-04-17

    (36 days)

    Product Code
    Regulation Number
    880.2420
    Why did this record match?
    Applicant Name (Manufacturer) :

    EM-TEC GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Low Fluid Alarm System is a stand alone accessory for monitoring of liquid levels (standard saline solutions or other solutions with an aqueous base) in a reservoir. It is generally useable with rigid polycarbonate, flexible polyvinyl chloride (PVC) or glass reservoirs. If the level falls below a predetermined threshold visual and acoustical alarms appear. The Low Fluid Alarm System is designed for continuous arthroscopy operation in operating rooms and intensive care units. For the patient's safety the device is to be operated only by qualified medically-trained personnel and only with constant supervision.
    Device Description
    Not Found
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    K Number
    K040909
    Device Name
    SONO TT ULTRASONIC FLOWCOMPUTER
    Manufacturer
    Date Cleared
    2004-04-20

    (12 days)

    Product Code
    Regulation Number
    870.2100
    Why did this record match?
    Applicant Name (Manufacturer) :

    EM-TEC GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sono TT Ultrasonic Flowcomputer in combination with an ultrasonic clamp-on Transducer is indicated for the contact less volumetric measurement of liquid flowing through tubing systems. The measurement principle is the ultrasound transit-time method. The medical use of the device is appropriate in the following extracorporeal procedures: - Cardio-pulmonary bypass, membrane-oxygenation, hemodialysis, hemofiltration, plasmapheresis - Perfusion, infusion, transfusion - Several shunt-applications The Flowcomputer can be used in intensive care units and operating rooms. For the patient's safety the device is to be operated only by qualified medically-trained personnel.
    Device Description
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