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510(k) Data Aggregation

    K Number
    K171423
    Device Name
    Nasal Alar SpO2 Sensor
    Manufacturer
    Xhale, Inc
    Date Cleared
    2017-07-27

    (73 days)

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

    Xhale, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nasal Alar SpO2 Sensor is indicated for single patient use for continuously noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients (at least 4 years and older and weighing >15 kg), who are well or poorly perfused. The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision.
    Device Description
    The Nasal Alar SpO2 Sensor is a disposable, single patient use Pulse Oximetry sensor designed to attach to the patient's nasal alar region - the fleshy region at the side of the nose. Skin contact and adhesive free sensor retention is via soft silicone rubber cushions encapsulating the optical components. The Nasal Alar SpO2 Sensor with its associated patient cable terminates in a DB-9 connector compatible with monitors employing Nellcor SpO2 technology. The sensor utilizes red and IR LED light sources of 660 nm and 890 nm respectively along with a silicon photodiode detector to detect changes in oxygen saturation in the blood. Since oxygen saturated blood absorbs different amounts of light at each wavelength (red and infrared) as compared with unsaturated blood, the amount of light absorbed at each wavelength by the blood in each pulse can be used to calculate oxygen saturation.
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    K Number
    K143216
    Device Name
    Assurance Alar / Nasal SpO2 Sensor
    Manufacturer
    Xhale, Inc.
    Date Cleared
    2015-03-17

    (127 days)

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

    Xhale, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Assurance™ Nasal / Alar SpO2 Sensor is indicated for single patient use for continuously noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients (weighing > 30kg), who are well or poorly perfused. The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision.
    Device Description
    The Alar / Nasal SpO2 Sensor is a disposable, single patient use Pulse Oximetry sensor designed to attach to the patient's nasal alar region - the fleshy region at the side of the nose. Skin contact and adhesive free sensor retention is via soft silicone rubber cushions encapsulating the optical components. The Alar / Nasal SpO2 Sensor with its associated patient cable, terminates in a DB-9 connector compatible with monitors employing Nellcor SpO2 technology. The sensor utilizes red and IR LED light sources of 660 nm and 880 nm respectively along with a silicon photodiode detector to detect changes in oxygen saturation in the blood. Since oxygen saturated blood absorbs different amounts of light at each wavelength (red and infrared) as compared with unsaturated blood, the amount of light absorbed at each wavelength by the blood in each pulse can be used to calculate oxygen saturation.
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    K Number
    K122996
    Device Name
    ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085
    Manufacturer
    XHALE
    Date Cleared
    2013-04-10

    (195 days)

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

    XHALE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Assurance™ Alar Sensor is indicated for single patient use for continuous noninvasive monitoring of functional arterial oxygen saturation and pulse rate from the nasal alar of adult and pediatric patients, (weighing >30kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision.
    Device Description
    The Assurance™ Alar Sensor is a disposable, single patient use Pulse Oximetry sensor designed to attach to the patient's nasal alar region - the fleshy region at the side of the nose. Skin contact and adhesive free sensor retention is via soft silicone rubber cushions encapsulating the optical components. The Assurance™ Alar Sensor with its associated patient cable, terminates in a DB-9 connector compatible with monitors employing Nellcor OxiSensor II SpO2 technology such as the Nellcor N-395. The sensor utilizes red and IR LED light sources of 660 nm and 890 nm respectively along with a silicon photodiode detector to detect changes in oxygen saturation in the blood. Since oxygen saturated blood absorbs different amounts of light at each wavelength (red and infrared) as compared with unsaturated blood, the amount of light absorbed at each wavelength by the blood in each pulse can be used to calculate oxygen saturation.
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