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510(k) Data Aggregation

    K Number
    K110957
    Device Name
    M4 MONITOR
    Manufacturer
    SPECTRUM MEDICAL, LLP
    Date Cleared
    2011-05-31

    (56 days)

    Product Code
    DRY
    Regulation Number
    870.4330
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPECTRUM MEDICAL, LLP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the M4 Monitor is for the non-invasive continuous monitoring of O2 saturation, hematocrit and haemoglobin concentration, blood flow, gaseous emboli, Temperature, PO2, and PCO2, in an extracorporeal circuit. The device provides monitoring information to trained clinicians and can be configured by them to set parameter specific alarms.
    Device Description
    The Spectrum M4 Monitor consists of a 10.4 inch high definition touch screen and sensor assemblies connected to a flat panel display unit. Optical sensor assemblies are used to collect data for the measurement of Arterial and Venous Saturation and Hot / Hb. Ultrasonic sensors are used to collect data for the measurement of flow and gaseous emboli. A thermistor is used for the collection of temperature data. Inlet and outlet gas measurements sensors are used to collect data for the measurement of PO2, and PCO2. Parameter values are displayed in both a digital and trended format. The M4 Monitor has been designed to self-detect the selected sensor and to automatically configure the required parameter display screens. The device can be configured by the trained clinician to set parameter specific alarms and to select either the display of hematocrit or haemoqlobin concentration. Session data can be stored to a memory card supplied with the system, via a RS232 link or wirelessly to a remote computer. The M4 Monitor is powered from the AC Mains supply and also incorporates a battery back-up that automatically switches on in the event of an interruption to the mains power supply. The system weighs 4.5 kg and is supplied with a pole mount clamp.
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    K Number
    K062468
    Device Name
    SPECTRUM M2 MONITOR
    Manufacturer
    SPECTRUM MEDICAL, LLP
    Date Cleared
    2006-09-13

    (20 days)

    Product Code
    DRY
    Regulation Number
    870.4330
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPECTRUM MEDICAL, LLP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The M2 Monitor is intended as a device for the non-invasive continuous monitoring of oxygen saturation of the blood in an extracorporeal circuit. The device provides monitoring information to trained clinicians and can be configured by them to alarn for set saturation levels.
    Device Description
    The Spectrum M2 Monitor consists of a 10.4 inch high definition touch screen and two active measuring channels mounted into a flat panel unit. Sensor cables are used to connect one or both measuring channels to the external surface of extracorporeal blood line tubing. The sensor cable head contains a light emitting diode that sends light through the extracorporeal tube, which illuminates the flowing blood. The reflected spectra is collected by a fibre optic cable and quantified by a photo-detector contained within a spectrometer. These spectra are compared to reference spectra by the monitor's software to determine the oxygen saturation of the blood in the extracorporeal line. The oxygen saturation levels for venous blood flow alone or both venous and arterial can be displayed by using one or both sensor channels. A trace of these oxygen levels are also displayed on the monitor. The M2 Monitor has been designed to selfdetect the selected sensor and to automatically configure the required parameter display screens. The device can be configured by the trained clinician to alarm for set saturation levels on either channel and to record session data onto a memory card supplied with the system. The M2 Monitor is powered from the AC Mains supply and also incorporates a battery back-up that automatically switches on in the event of an interruption to the mains power supply. The system weighs 4.5 kg and is supplied with a pole mount clamp.
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