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510(k) Data Aggregation

    K Number
    K111007
    Device Name
    MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE
    Manufacturer
    MIDWEST REPROCESSING CENTER LLC
    Date Cleared
    2011-06-08

    (58 days)

    Product Code
    NMD
    Regulation Number
    870.2700
    Why did this record match?
    Product Code :

    NMD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Midwest Reprocessing Center (MRC) Reprocessed Cerebral-Somatic Oximetry Sensors are indicated for use when continuous noninvasive trending of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor is required.
    Device Description
    Midwestern Reprocessing Center (MRC) Reprocessed Cerebral-Somatic Oximetry Sensors (CSS) are optical devices which use dual-wavelength light to determine a patient's current regional oxygen saturation level. Once a sensor has been applied to the patient, a light source in the sensor sends red and near-infrared light through the skin surface and photodiodes measure the reflected light. This signal is sent back to a monitor which calculates the patient's trending oxygenation levels.
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    K Number
    K100523
    Device Name
    ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA
    Manufacturer
    HYGIA HEALTH SERVICES, INC.
    Date Cleared
    2010-05-04

    (69 days)

    Product Code
    NMD
    Regulation Number
    870.2700
    Why did this record match?
    Product Code :

    NMD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hygia Health Services Reprocessed Pediatric and Adult Cerebral-Somatic Oximetry Sensors are indicated for use when continuous noninvasive oxygen saturation is required for pediatric patients weighing < 40 kg and adult patients weighing > 40 kg, respectively. The Hygia reprocessed sensor has been validated with the OEM's Cerebral/Somatic Oximeter, Model 5100C and is intended to be used with the Cerebral/Somatic Oximeter, Model 5100C only. The noninvasive 5100C Cerebral/Somatic Oximeter is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. It is intended for use in any individual at risk for reduced-flow or no-flow ischemic states. The prospective clinical value of data from the 5100C Cerebral/Somatic Oximeter has not been demonstrated in disease states. The OEM suggests the 5100C Cerebral/Somatic Oximeter should not be used as the sole basis for diagnosis or therapy.
    Device Description
    The Hygia Health Services Reprocessed Cerebral-Somatic Oximetry Sensors (CSS) are optical devices which use dual-wavelength light to determine a patient's current regional oxygen saturation level. Once a sensor has been applied to the patient, a light source in the sensor sends red and near-infrared light through the skin surface and photodiodes measure the reflected light. This signal is sent back to a monitor which calculates the patient's trending oxygenation levels.
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