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510(k) Data Aggregation

    K Number
    K210305
    Device Name
    Pulse Oximeter
    Date Cleared
    2021-12-22

    (322 days)

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

    Dongguan Lingxin Technologies Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OX201 Pulse Oximeter is a non-invasive device intended for prescription use spot-check of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients (weight ≥ 40kg) in home, hospital and clinic environments. The device is not intended for continuous monitoring, use during motion or use with low perfusion.
    Device Description
    The OX201 pulse oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rage (PR) of single adult and pediatric patient in home and hospital. The fingertip pulse oximeter features small size, low power consumption, convenient operation and portability. Power consumption of the product is low and two AAA batteries can be operated continuously for 24 hours. It is only necessary for a patient to put one of his/her fingers into the fingertip clips for measurement, use it very easy. Principle of the fingertip pulse oximeter as follows: A mathematical formula is established making use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin (RHb) and Oxyhemoglobin (HbO2) in glow and near-infrared zones. Operation principle of the instrument: Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights (660nm glow and 905nm near infrared light) can be focused onto a human nail tip through a clamping finger-type sensor. Relevant dada is shown on the Oximeter's display through electronic circuits and a microprocessor.
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