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510(k) Data Aggregation

    K Number
    K100928
    Device Name
    MICRO DIARY SPIROMETER
    Manufacturer
    VIASYS RESPIRATORY CARE INC.
    Date Cleared
    2011-03-07

    (336 days)

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

    VIASYS RESPIRATORY CARE INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Micro Diary Spirometer is used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs. Specifically, the Micro Diary Spirometer measures the following lung function parameters: FEV1, FVC, FEV6 and PEF. The device also records the test data for later review and has the ability to transfer these test records to a compatible computer.
    Device Description
    The Micro Diary Spirometer is a compact, hand held, and battery operated recording spirometer. The device features a five button keypad and an LCD display. The device utilizes a digital volume transducer. As a patient's exhaled breath is passed through the transducer, the vane rotates. The number of rotations is proportional to the volume of air passed through the transducer, and the frequency of rotation is proportional to the flow rate.
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    K Number
    K073069
    Device Name
    MODIFICATION TO AVEA VENTILATOR
    Manufacturer
    VIASYS RESPIRATORY CARE INC
    Date Cleared
    2008-01-25

    (87 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIASYS RESPIRATORY CARE INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on adult, pediatric, and neonatal patients. It should only be operated by properly trained clinical personnel, under the direction of a physician.
    Device Description
    The AVEA is a servo-controlled, software-driven ventilator. It has a dynamic range of breathing gas delivery that provides for neonatal through adult patients. Its graphical user interface module (UIM) has a flat panel color LCD with real time charting and digital monitoring capabilities, a touch screen for interaction, membrane keys and a dial for changing settings and operating parameters. It also has an internal gas delivery system with servo controlled active inhalation and exhalation functions. Using internal batteries this provides inter-hospital transport as well as back up capability due to loss of AC power. The AVEA may be configured as a conventional ventilator or non-invasive positive pressure ventilator (NPPV). It has been designed to function using commonly available accessories.
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    K Number
    K062093
    Device Name
    AVEA VENTILATOR
    Manufacturer
    VIASYS RESPIRATORY CARE INC
    Date Cleared
    2006-09-20

    (58 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIASYS RESPIRATORY CARE INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on adult, pediatric, and neonatal patients. It should only be operated by properly trained clinical personnel, under the direction of a physician.
    Device Description
    The AVEA is a servo-controlled, software-driven ventilator. It has a dynamic range of breathing gas delivery that provides for neonatal through adult patients. Its graphical user interface module (UIM) has a flat panel color LCD with real time charting and digital monitoring capabilities, a touch screen for interaction, membrane keys and a dial for changing settings and operating parameters. It also has an internal gas delivery system with servo controlled active inhalation and exhalation functions. Using internal batteries this provides inter-hospital transport as well as back up capability due to loss of AC power. The AVEA may be configured as a conventional ventilator or non-invasive positive pressure ventilator (NPPV). It has been designed to function using commonly available accessories.
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