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510(k) Data Aggregation

    K Number
    K052119
    Device Name
    TESLAGUARD, MODEL EFT G04
    Manufacturer
    MAMMENDORFER INSTITUTE FOR PHYSICS & MEDICINE GMBH
    Date Cleared
    2006-01-03

    (152 days)

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

    **MAMMENDORFER INSTITUTE FOR PHYSICS **& MEDICINE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tesfacuard® Patient Monitor is capable of monitoring: - SpO2 (Arterial Oxygen Saturation) . - ECG (3-Lead) . - IBP (Invasive Blood Pressure) . - . NIBP (Non-invasive Blood Pressure) This device will produce visual and audible alarms if any of these parameters vary beyond preset limits. The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine when use of the device is indicated based upon their professional assessment of the patient's medical condition. The device is intended for use in the Adult, Pediatric and Neonatal populations. MRI Compatibility Statement: The Tesfa Guad® Patient Monitor is designed for use in an MRI-environment at a maximum magnetic field strength of 20mT.
    Device Description
    The Tesla Guard® design allows examination of intensive care patients while in an MRI-scanner. The Tesla Guard® construction, fiber optic finger probe, and additional shielding make it possible to use the device within the magnetic and RF fields of the MRI examination room. During use, the unit must be positioned in a way that the maximum field strength is not higher than 20 mT, and the distance to the magnet core is at least 1.5m.
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    K Number
    K050018
    Device Name
    TESLAOXYSAT, MODEL EFOXYSATE
    Manufacturer
    MAMMENDORFER INSTITUTE FOR PHYSICS & MEDICINE GMBH
    Date Cleared
    2005-07-01

    (178 days)

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

    **MAMMENDORFER INSTITUTE FOR PHYSICS **& MEDICINE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TeslaOxySat Pulse Oximeter is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The pulse oximeter is indicated for use with adult, pediatric, and neonatal patients. The TeslaOxySat PulseOximeter is designed for use in an MRI-environment at a maximum magnetic field strength of 20mT.
    Device Description
    The Tesla OxySat® design allows examination of intensive care or sedated patients while in an MRI-scanner. The Tesla OxySat® construction, fiber optic finger probe, and additional shielding make it possible to use the device within the magnetic and RF fields of the MRI examination room. During use, the unit must be positioned in a way that the maximum field strength is not higher than 20 mT, and the distance to the magnet core is at least 1.5m.
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    K Number
    K030323
    Device Name
    MRI-CADDY
    Manufacturer
    MAMMENDORFER INSTITUTE FOR PHYSICS & MEDICINE GMBH
    Date Cleared
    2003-04-02

    (62 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    **MAMMENDORFER INSTITUTE FOR PHYSICS **& MEDICINE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended medical application of MRI-Caddy with three 2000-Series syringe pumps is to produce controlled movement of the plunger of a syringe to inject a set amount of therapeutic fluid into a patient within a hospital setting at a set rate and at set times. The MRI-Caddy is designed for use in an MR-environment at a maximum magnetic field strength of 20mT.
    Device Description
    The MRI-Caddy® is a cart with an integrated chassis, which is equipped with three Medex syringe pumps and a power supply. The MRI-Caddy's mechanical construction makes it possible to position the system with the MR-room. For this purpose the system was equipped with adequate screening following the principle of a Faraday cage. The function principle corresponds to that of the Medex syringe pumps already on the market.
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