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510(k) Data Aggregation

    K Number
    K173368
    Device Name
    Reusable & Disposable SpO2 Sensors
    Date Cleared
    2018-08-31

    (309 days)

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

    Shenzhen Coreray Technology, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Coreray Reusable SPO2 Sensor is intended to be used in hospital settings where patient care is offered by qualified healthcare personnel. The Reusable SPO2 Sensor is intended for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR) for adult patients weighing greater than 40kg.
    Device Description
    The Reusable SPO2 Sensor is comprised of a connector and a cable which terminates into sensor housing. The sensor contains two specific wavelength LEDs and a photo detector assembled into the sensor housing which separate by one housing half and the other half. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. One type of sensor housing is described in this submission: Reusable finger clip sensor. The sensor has a labeling and specifications designed for compatibility with a specific monitor.
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