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510(k) Data Aggregation

    K Number
    K172616
    Device Name
    Pulse Oximeter
    Date Cleared
    2018-07-27

    (330 days)

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

    Beijing Safe Heart Technology Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    PULSE OXIMETER SHO-3002,SHO-3006 and SHO-3008 is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult at hospital (including clinical use internist/surgery, Anesthesia etc ).It is not for continuously monitoring.
    Device Description
    The devices consist of detector and emitter LED, CPU, display unit and power unit. The Pulse oximeter is a kind of innovated medical detection device with non-invasive and continuous features for arterial SPO2 and PR detection. The proposed device consists of photo detector and emitter, LED, CPU, data display unit and power unit. It is portable and easy to measure the SPO2 and PR value quickly and precisely. The series of pulse oximeter detect the body's oxygen saturation and pulse rate through the fingers. The device does not contain drug or biological products. The power sources of the proposed devices are 2 AAA alkaline batteries. All the proposed devices have low battery voltage indicator function, and all the proposed devices will automatically power off when there is no signal for longer than 5 seconds. The proposed devices are not for life-supporting or life-sustaining, not for implant. The devices or transducers are not sterile and the transducers are reusable and do not need sterilization. The devices are for prescription. The devices do not contain drug or biological products. The Pulse oximeter SHO-3002, SHO-3006 and SHO-3008 share the same measurement principle and oximeter sensor and oxygen saturation module and power supply. The indented target population and use environment of the Pulse oximeter SHO-3002, SHO-3006 and SHO-3008 are the same. The devices are software-driven and the software validation is provided in Section of Software.
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