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510(k) Data Aggregation

    K Number
    K210032
    Device Name
    Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)
    Manufacturer
    Leadtek Research Inc.
    Date Cleared
    2021-09-01

    (239 days)

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

    Leadtek Research Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fingertip Pulse Oximeter (Wireless) are intended for measuring function of arterial hemoglobin (SpO2) and pulse rate for both adults and adolescent as non-invasive spot checking in home and professional caring environment. It is designed for fingers between 0.8cm and 2.3cm (0.3 inches) and for patients during nomotion condition.
    Device Description
    The main function of the Fingertip Pulse Oximeter (Wireless) is to measure the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate as non-invasive spot checking monitoring. The subject determines the functional oxygen saturation of arterial hemoglobin (SpO2) by measuring the absorption of red and infrared light passing through perfused tissue. Changes in absorption caused by the pulsation of blood in the vascular bed are used to determine SpO2 reading and pulse rate. The characteristic of the device is a stand-alone device with 1 AAA Alkaline battery. It includes an OLED display screen and a warning or indicator function for abnormal readings. The Fingertip Pulse Oximeter (Wireless) is also built in with a Bluetooth low energy (BLE) function to perform data transmission.
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    K Number
    K193350
    Device Name
    Leadtek Fingertip Pulse Oximeter
    Manufacturer
    Leadtek Research Inc.
    Date Cleared
    2020-04-27

    (146 days)

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

    Leadtek Research Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Leadtek Fingertip Pulse Oximeter are intended for measuring functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for both adults and adolescent as non-invasive spot checking in home and professional caring environment. It is designed for fingers between 0.8cm and 2.3cm (0.3 inches to 0.9 inches) and for patients during no-motion condition.
    Device Description
    The main function of the Leadtek Fingertip Pulse Oximeter is to measure the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate as non-invasive spot checking. The Fingertip Pulse Oximeter determines the functional oxygen saturation of arterial hemoglobin (SpO2) by measuring the absorption of red and infrared light passing through perfused tissue. Changes in absorption caused by the pulsation of blood in the vascular bed are used to determine SpO2 reading and pulse rate. The characteristic of the device is a stand-alone device with 1 AAA Alkaline battery. It includes an OLED display screen and a warning or indicator function for abnormal readings.
    Ask a Question

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