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510(k) Data Aggregation

    K Number
    K211632
    Device Name
    Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)
    Manufacturer
    Shenzhen Narig Bio-Medical Technology Co., Ltd.
    Date Cleared
    2022-01-14

    (232 days)

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

    Shenzhen Narig Bio-Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The pulse oximeter is indicated for the noninvasive spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatic (≥10Kg) patients during both no motion and for patients who are well or poorly perfused. Pulse Oximeter is intended for hospitals, hospital-type facilities, home environments.
    Device Description
    The Pulse Oximeter is a small, lightweight, portable, digit pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO₂), pulse rate (PR) and perfusion index (PI) by measuring the absorption of red and infrared light passing through perfused tissue. It indicated for adult and pediatric (≥10Kg) patients during both no motion and motion conditions, and for patients who are well or poorly perfused. The device consists of probe, electronic circuits, OLED/LED display (differentiated by models) and plastic housing which powered by two alkaline AAA batteries.
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