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510(k) Data Aggregation

    K Number
    K201082
    Device Name
    LTV2 Series Ventilators
    Manufacturer
    Vyaire Medical Inc
    Date Cleared
    2021-11-10

    (566 days)

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

    Vyaire Medical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LTV2 model 2200 and 2150 ventilators are intended to provide continuous or intermittent ventilator support for the care of the individuals who require mechanical ventilation. The use environment is for institutional use. Institutional use includes ICU or other hospital environments including intra-hospital transport. The model 2200 can operate with high pressure O2. The model 2150 operates with low pressure oxygen. TheLTV2 Series Ventilators are intended to provide continuous or intermittent ventilatory support for the care of the individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lbs.), who require the following types of ventilatory support: - . Positive Pressure Ventilation, delivered invasively or non-invasively (via mask). - . Assist/Control, SIMV, CPAP, and NPPV modes of ventilation. The ventilator is suitable for use in professional healthcare facilities, including during intrahospital transport.
    Device Description
    The LTV2 Series ventilator supports adult and pediatric patients weighing at least 10 kg (22 lb) in professional healthcare facilities response with invasive or noninvasive ventilation presets. These settings can be easily refined using the touch-turn-touch interface on the LED display. The ventilator also provides a wide range of ventilation therapies to meet demanding patient needs, including volume control, pressure control, pressure support and spontaneous breath types. Combined with the spontaneous breathing trial function, the ultra-sensitive flow trigger facilitates weaning patients weighing at least 10 kg (22lb).
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    K Number
    K190853
    Device Name
    Vyntus BODY
    Manufacturer
    Vyaire Medical Inc.
    Date Cleared
    2019-08-16

    (136 days)

    Product Code
    BZC, BTY, JEH
    Regulation Number
    868.1880
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vyaire Medical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vyntus BODY is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, aiding in the diagnosis of related conditions. All the measurements are performed via a mouthpiece, a mask or nasal adapters. The results of the test can be viewed online with the help of a computer screen and can be printed after the test. The test results can be saved for future reference or report generation purposes. The products can be utilized with patients aged 4 years and older as long as they can cooperate in the performance - no special limit to patient's sex or height exists. Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar setting (professional healthcare facilities). A qualified physician has to reassess all Vyntus BODY measurements. An interpretation by SentrySuite is only significant if it is considered in connection with other clinical findings.
    Device Description
    The Vyntus BODY is a whole-bodyplethysmograph and consists of the Vyntus BODY cabin, an ultrasonic flow sensor (USS), and a shutter. The Vyntus BODY system allows the determination of a subjects' pulmonary function status. It includes the determination of the subjects' ventilatory flows and volume by means of the USS. The measurement of the lung diffusion by the DLCO technique is accomplished with the supply of test gas and the gas analyzers for methane (CH4) and carbone monoxide (CO). All variants are stationary and not battery operated. The sensor data is sent to a host computer system via cable connection for processing, storage, and reporting. The host computer can be networked via LAN, WLAN, or Internet. All measurements are performed with the use of the Windows based operating software SentrySuite (SeS). The SeS software also stores the measurement results and provides output capabilities. The host computer, monitor, and printer are mounted on the Vyntus Cart. Use of the cart is optional; computing equipment may be placed on other furniture.
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