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510(k) Data Aggregation

    K Number
    K063434
    Device Name
    TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM
    Manufacturer
    RADIOMETER BASEL AG
    Date Cleared
    2007-01-22

    (70 days)

    Product Code
    DQA, DPZ, LKD
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIOMETER BASEL AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TOSCA 500 Monitoring System is designed for the simultaneous continuous monitoring of transcutaneous PCO₂, functional oxygen saturation SpO₂ and Pulse Rate in adults and pediatrics.
    Device Description
    The TOSCA 500 Monitoring System is designed for the simultaneous continous monitoring of transcutaneous PCQ2, functional oxygen saturation SpO2 and pulse rate, using a single sensor (TOSCA Sensor). The system consists of a TOSCA Monitor equipped with an integrated calibration unit which allows a fully automatic calibration of the PCQz part of the sensor and also provides a storage facility for the sensor, and with the Masimo SET signal extraction technology for the calculation of the functional oxygen saturation and the pulse rate ; a TOSCA Sensor comprising the elements of an electrochemical Stow-Severinghaus-type carbon dioxide sensor and of an optical pulse oximelty sensor; supplies for the sensor preparation; supplies for the sensor attachment to the patient, and a gas mixture for the sensor calibration. With the new TOSCA Fixation Rings 32mm (subject of this new 510(k)), the TOSCA sensor may be battled to the forehead or the cheek, and to other conventional mesuring sites for the for the for the for the for treacurement only measurement only.
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