Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K163382
    Device Name
    Oxitone 1000
    Manufacturer
    Oxitone Medical Ltd.
    Date Cleared
    2017-05-09

    (159 days)

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

    Oxitone Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oxitone Model 1000 Pulse Oximeter is a small, wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate. It is intended for spot-checking of adult patients with wrist between 13-22 cm circumferences in hospitals, clinics, long-term care, and home use.
    Device Description
    The Oxitone 1000 pulse oximeter is an instrument for photoelectrically determining the oxygenation of blood in a part of the body, in this case the wrist. This Oxitone 1000 contains the electronics, interface and sensor. The Oxitone pulse oximeter is mounted on a watch-like device and measures oxygen saturation at the wrist location. The Oxitone pulse oximeter exploits a reflectance sensor that includes the photodetector located at the wearer's Ulnar Bone near the Ulnar Bulge and a bi-color light source (LED's) that are located around the top of the wearer's Ulnar "Bulge", to align the light source properly to the Ulnar Bulge the LEDs surrounded by elastic concave shape surface. The Red and infrared light being transmitted through the tissue is partially absorbed by the blood oxyhemoglobin and is sensed by the photodetector. The blood oxygen saturation is measured using the well-established technology where the red and infrared light is absorbed in different amounts depending on the oxygenation of the blood that enables to calculate the blood functional pulse oximetry. The Oxitone 1000 has the ability to determine both the percent of saturated hemoglobin and the pulse rate. It performs these functions on adult patient populations. It is designed for spot checking both the SpO2 and Pulse rate information. To perform this, the Oxitone 1000 displays digital values for both the SpO2 and Pulse. Pulse amplitude is not displayed. The Oxitone 1000 is powered by an integral rechargeable Lithium Ion battery pack. The wavelength of red LED is 640nm and Infrared LED is 940 nm with maximum optical output power of less than 1 mW. The device incorporates a battery state indicator and provides a visual indication of low battery.
    Ask a Question

    Page 1 of 1