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510(k) Data Aggregation

    K Number
    K200414
    Device Name
    Pulse Oximeter
    Manufacturer
    Shenzhen Aeon Technology Co., Ltd.
    Date Cleared
    2020-09-23

    (217 days)

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

    Shenzhen Aeon Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in clinical institution and home environments.
    Device Description
    The Pulse Oximeter is a battery powered device intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 905 nm, which is Infrared light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The device mainly composed of PCB board, On/Off button, mode button, OLED&LED screen, battery compartment, Bluetooth® module and plastic shell. The device has wireless connection via Bluetooth®. The device is a spot-check pulse oximeter and does not include alarms. The device is not intended for life-supporting or life-sustaining.
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    K Number
    K190869
    Device Name
    Pulse Oximeter
    Manufacturer
    Shenzhen Aeon Technology Co., Ltd.
    Date Cleared
    2019-09-13

    (163 days)

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

    Shenzhen Aeon Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in clinical institution and home environments.
    Device Description
    The Pulse Oximeter is a battery powered device intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 mm, which is red light; the other is 905 nm, which is Infrared light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. This equipment mainly composed of PCB board, On/Off button, mode button, OLED&LED screen, battery compartment, and plastic shell. The device is a spot-check pulse oximeter and does not include alarms. The device is not intended for life-supporting or life-sustaining.
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