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510(k) Data Aggregation

    K Number
    K163135
    Device Name
    Finger Pulse Oximeter
    Manufacturer
    SHENZHEN FITFAITH TECHNOLOGY CO.,LTD
    Date Cleared
    2017-09-19

    (315 days)

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

    SHENZHEN FITFAITH TECHNOLOGY CO.,LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fingertip 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 Fingertip Pulse Oximeteris intended for spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of adult and pediatric patients in the home and hospital. The fingertip pulse oximeter features a small size, low power consumption, a convenient operation, and portability.It is only necessary for a patient to put one of his/her fingers into the fingertip clips for measurement. 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 red and 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 red and 905nm infrared light) can be focused onto a human nail tip through a clamping finger-type sensor. Relevant data is shown on the Oximeter's display through electronic circuits and a microprocessor.
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