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510(k) Data Aggregation

    K Number
    K103685
    Device Name
    PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA
    Date Cleared
    2011-07-15

    (210 days)

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

    **BEIJING RONGRUI-CENTURY SCIE. **& TECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Pulse Oximeter Sensor is indicated for non-invasive spot checking and/or continuous monitoring of arterial oxygen saturation and pulse rate of the adult or neonatal patients with oximeter equipment in hospitals, hospital-type facilities, and home care environments. The Reusable Pulse Oximeter Sensors are indicated for non-invasive spot checking and/or continuous monitoring of arterial oxygen saturation and pulse rate of the adult or pediatric patients with oximeter equipment in hospitals, hospital-type facilities, and home care environments.
    Device Description
    The proposed devices of the Pulse Oximeter Sensors (Disposable and Reusable), are used in conjunction with oximeter equipment to measure and display the arterial oxygen saturation of blood.
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