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510(k) Data Aggregation
K Number
K190853Device Name
Vyntus BODY
Manufacturer
Vyaire Medical Inc.
Date Cleared
2019-08-16
(136 days)
Product Code
BZC, BTY, JEH
Regulation Number
868.1880Why 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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