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510(k) Data Aggregation

    K Number
    K040178
    Device Name
    PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE
    Manufacturer
    S.P.O. MEDICAL EQUIPMENT, LTD.
    Date Cleared
    2004-09-10

    (228 days)

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

    S.P.O. MEDICAL EQUIPMENT, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SPO PulseOx 5500 Pulse Oximeter is indicated for use for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients in hospitals, medical facilities, home care, transport and sub-acute environment. The SPO PulseOx 7500 Pulse Oximeter, a small, wrist-worn device, is indicated for use in measuring, displaying and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It may be used for spot checking and/or data collection and recording of adult and pediatric patients in hospitals, medical facilities, ambulatory, sub-acute and sleep study environments.
    Device Description
    The SPO PulseOx pulse oximeter devices monitor the oxygen saturation levels in the blood using pulse oximetry, i.e., changes in light intensity as the light is reflected back from human tissue. Two different wavelengths (in the visible and infrared wavelength) are used. Comparisons between the standard signal and the variances can be used to calculate the oxygen saturation of arterial blood. The SPO PulseOx pulse oximeter devices are based on the reflective method whereby the sensor is located on one side of the relevant body part so as to measure the necessary parameters. The main components of the SPO pulse oximeter devices are a sensor block, analog block, controller, LCD display and battery.
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