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510(k) Data Aggregation

    K Number
    K203854
    Device Name
    Pulse Oximeter
    Manufacturer
    Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd.
    Date Cleared
    2021-04-23

    (113 days)

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

    Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The portable fingertip device is indicated for adult and pediatric patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).
    Device Description
    The Pulse Oximeter is intended for measuring the functional oxygen saturation and pulse rate (PR) through a patient's finger. It is applicable for spot-checking SpO2 and pulse rate (PR) of adult and pediatric patients in homes and clinics. The Pulse Oximeter is as a stand-alone device, which is powered by an internal battery. The device is for multi-use. The device is not for life supporting or life sustaining, not for implant. The device is not sterile, the device is not a reprocessed single-use device, and the device does not contain drug or biological products.
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