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510(k) Data Aggregation

    K Number
    K231416
    Device Name
    Air Next (NVD-02)
    Manufacturer
    NuvoAir AB
    Date Cleared
    2024-01-18

    (247 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    NuvoAir AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NuvoAir Air Next is intended to test lung function and spirometry in adults and children 5 years of age and older. It can be used in hospitals, in the clinical setting, and at home. The Air Next is not intended for use in an operating room. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
    Device Description
    Air Next is intended to perform basic lung function and spirometry testing. It measures parameters such as the forced expiratory volume in 1 sec (FEV1) and the forced vital capacity (FVC) in a forced expiratory maneuver. These measures can be used for detection, assessment and monitoring of diseases affecting the lung function, such as bronchial Asthma, COPD and Cystic Fibrosis. Air Next is a hand-held spirometer, weighing 75g and it is powered by 2 AAA alkaline 1.5V batteries. It consists of 3 main components: the Air Next device, the NuvoAir disposable turbine (delivered in one package) and the Air Next mobile application downloadable from Apple's and Google's Play Stores.
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    K Number
    K183089
    Device Name
    Air Next
    Manufacturer
    NuvoAir AB
    Date Cleared
    2020-01-02

    (422 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    NuvoAir AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Air Next is intended to be used by: Healthcare professionals trained to perform spirometry tests on patients of age ≥ 5 years old, > 10 kg and > 110 cm. Air Next is intended to perform basic lung function and spirometry testing. The actual diagnosis shall be done by a healthcare professional in hospital and clinical settings.
    Device Description
    Air Next is intended to perform basic lung function and spirometry testing. It measures parameters such as the forced expiratory volume in 1 sec (FEV1) and the forced vital capacity (FVC) in a forced expiratory maneuver. These measures can be used for detection, assessment and monitoring of diseases affecting the lung function, such as bronchial Asthma, COPD and Cystic Fibrosis. Air Next is a hand-held spirometer, weighing only 75g and it is powered by 2 AAA alkaline 1.5V batteries. lt consists of 3 main components: the Air Next device, the NuvoAir disposable turbine (delivered in one package) and the Air Next mobile application downloadable from Apple's and Google's Play Stores. The package includes one Air Next device, one NuvoAir disposable turbine through which the user can start using the Air Next, two AAA 1.5V alkaline batteries, one user manual and one cotton bag to carry the device. Dimensions of the Air Next are 98 x 62 x 26 mm, which can be seen in the engineering drawing in the attachments.
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