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510(k) Data Aggregation

    K Number
    K120635
    Device Name
    EASYONE PRO RESPIRATORY TESTING DEVICE
    Manufacturer
    NDD MEDIZITECHNIK AG
    Date Cleared
    2012-09-27

    (210 days)

    Product Code
    BTY
    Regulation Number
    868.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    NDD MEDIZITECHNIK AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ndd EasyOne Pro Respiratory Analysis System is designed for conducting lung function measurements in general or specialist practices or in hospitals. The EasyOne Pro Respiratory Analysis System can also be used outside of the laboratory when performing lung function screenings or measurements in occupational medicine. The EasyOne Pro Respiratory Analysis System is used to conduct lung function measurements on adults and children starting at age 4, except measurements of Diffusing Capacity of the lung based on CO (DLCO), which can be performed on adults and children starting at age 6.
    Device Description
    The ndd EasyOne Pro Respiratory Analysis System is a portable device for performing lung function measurements. The device consists of a compact main unit and a hand-held sensor. Spirometry tests can be performed by connecting the hand-held sensor to the main unit. In order to perform DLCO and FRC tests a valve unit must additionally be connected to the handheld sensor. The valve unit is connected with the main unit with a gas supply tube. The spirette respiratory tube is a mouthpiece for single patient use, which is inserted in the sensor. In the valve unit there is also an accessory for single patient use inserted, which is called barriette. The barriette prevents the passage of microorganisms into EasyOne Pro Respiratory Analysis System. A touch screen is integrated in the main unit that provides the user interface. The main power switch, different connections as well as different ports are located on the rear panel of the main unit. The EasyOne Pro can be used as a stand-alone system and can be connected to a network. The device has built-in quality control to assure correct test performance and equipment function.
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    K Number
    K091428
    Device Name
    EASYONE PRO RESPIRATORY ANALYSIS SYSTEM
    Manufacturer
    NDD MEDIZITECHNIK AG
    Date Cleared
    2010-01-27

    (258 days)

    Product Code
    BTY
    Regulation Number
    868.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    NDD MEDIZITECHNIK AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ndd EasyOne Pro Respiratory Analysis System is designed for conducting lung function measurements in general or specialist practices or in hospitals. The EasyOne Pro Respiratory Analysis System can also be used outside of the laboratory when performing lung function screenings or measurements in occupational medicine. The EasyOne Pro Respiratory Analysis System is used to conduct slow and forced spirometry on adults and children starting at age 4. Measurement of Diffusing Capacity of the lung based on CO (DLCO) can be performed on adults and children starting at age 6.
    Device Description
    The ndd EasyOne Pro Respiratory Analysis System is a portable device for performing lung function measurements such as spirometry and diffusion capacity (DLCO) tests. Measured lung function parameters can be compared to predicted normal values that are computed based on gender, age, and body height of the patient; the applied equations are available in literature and/or published standards. The device consists of a compact main unit and a hand-held sensor. Spirometry tests can be performed by connecting the hand-held sensor to the main unit. In order to perform DLCO tests a valve unit must additionally be connected to the hand-held sensor. The valve unit is connected with the main unit with a gas supply tube. The spirette respiratory tube is a mouthpiece for single patient use, which is inserted in the sensor. In the valve unit there is also an accessory for single patient use inserted, which is called barriette. The barriette prevents the passage of microorganisms into EasyOne Pro Respiratory Analysis System. A touch screen is integrated in the main unit that provides the user interface. The main power switch, different connections as well as different ports are located on the rear panel of the main unit. The EasyOne Pro can be used as a stand-alone system and can be connected to a network. The device has built-in quality control to assure correct test performance and equipment function.
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    K Number
    K090034
    Device Name
    EASY ON-PC SPIROMETER
    Manufacturer
    NDD MEDIZITECHNIK AG
    Date Cleared
    2009-06-02

    (147 days)

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

    NDD MEDIZITECHNIK AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ndd Medical Technologies Easy on-PC Spirometer is intended for prescriptions use only to conduct diagnostic spirometry testing of adults and pediatric patients over 4 years old, in general practice and specialty physician, industrial and hospital settings.
    Device Description
    Easy on-PC is a PC based diagnostic spirometer and consists of a PC software and the Easy on-PC sensor (Spiroson-AS). The Easy on-PC software is installed on a Windows based PC or laptop computer to which the Easy on-PC sensor is connected. In order to conduct simple diagnostic spirometry testing, the Easy on-PC sensor is used in combination with a commercially available disposable breathing tube with integrated mouthpiece (spirette). The sensor is an ultrasound flow sensor that measures the transit-time to determine flow velocity, volume and molar mass of the gas. The collected data is transferred to the PC for pulmonary function evaluation and data management. The results of the testing are stored in a database and reports can be displayed or printed.
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