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    K Number
    K153739
    Device Name
    MRI Patient Monitor TeslaDUO
    Manufacturer
    MIPM MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN
    Date Cleared
    2016-06-28

    (183 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIPM MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MRI Patient Monitor TeslaDUO is intended for monitoring of vital signs during MRI examinations (MRI procedures) of patients. The TeslaDUO is intended for use in the Adult and Pediatric populations for continuous monitoring of Pulse Oximetry (SpO2). The TeslaDUO is intended for use in the Adult, Pediatric and Neonatal populations for continuous monitoring of Non-Invasive Blood Pressure (NIBP). The TeslaDUO is intended for use by health care professionals.
    Device Description
    The MRI Patient Monitor TeslaDUO ("TeslaDUO") is a magnetic resonance compatible patient monitoring device for use in MRI rooms (HF-proof, magnet-resistant) to monitor and display data from vital signs sensors during MRI examinations (MRI procedures) of patients. It is capable of continuously monitoring and displaying data in graphic and numeric form from the following sensors/measurement modules: - Pulse Oximetry (SpO2 and Pulse Rate) - Non-Invasive Blood Pressure (NIBP and PR)
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    K Number
    K142032
    Device Name
    MRI PATIENT MONITORING SYSTEM TESLA M3
    Manufacturer
    MIPM MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN
    Date Cleared
    2015-05-07

    (286 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIPM MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MRI Patient Monitoring System Tesla M3 is intended for monitoring of vital signs during MRI examinations (MRI procedures) of patients. The Tesla M3 is intended for use in the Adult, Pediatric and Neonatal populations for the continuous monitoring of Electrocardiogram (ECG), Non-Invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Temperature, Respiration, Capnography (etCO₂), Oxygen and Anesthetic Agents. The Tesla M3 is intended for use in the Adult and Pediatric populations for the continuous monitoring of Pulse Oximetry (SpO2). The Tesla M3 is intended for use by health care professionals.
    Device Description
    The Tesla M3 is a MRI Patient Monitoring System that is intended to monitor and display vital signs during MRI examinations (MRI procedures) of patients. It is capable for continuous monitoring and displaying data from the following sensors/measurement modules in graphic and numeric form: - Electrocardiogram (ECG), - Pulse Oximetry (SpO2), - . Non-Invasive Blood Pressure (NIBP), - . Invasive Blood Pressure (IBP), - Temperature, Respiration, - Capnography (etCO2), and - . Oxygen and Anesthetic Agents
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