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510(k) Data Aggregation

    K Number
    DEN200076
    Device Name
    ORi
    Manufacturer
    Masimo Corporation
    Date Cleared
    2023-10-12

    (1025 days)

    Product Code
    QWE, OWE
    Regulation Number
    870.2720
    Why did this record match?
    Product Code :

    QWE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ORi feature is intended to be used in patients undergoing surgery as an adjunct to SpO2 for increased monitoring resolution of elevated hemoglobin oxygen saturation levels (e.g., due to the administration of supplemental oxygen). The ORi feature is indicated for the monitoring of hemoglobin oxygen saturation levels in patients 18 years and older (adults and transitional adolescents) on supplemental oxygen during no-motion conditions perioperatively in hospital environments.
    Device Description
    ORi is a device that provides an adjunct oximeter function that extends the monitoring resolution of hemoglobin oxygen saturation at elevated oxygen levels (e.g., due to the administration of supplemental oxygen). The feature is intended to be used in conjunction with SpO2 monitoring provided by a pulse oximeter. The ORi feature utilizes the similar principles of operation as pulse oximetry, utilizing hemoglobin wavelength absorption characteristics to determine relative blood oxygen saturation. Whereas SpO2 monitoring provides visibility to blood oxygen saturation in the transition from normoxia to hypoxia on the hemoglobin oxygen disassociation curve, ORi provides visibility to the transition from normoxia to hyperoxia.
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