(54 days)
VentView - a PC programm for displaying ventilation parameters and status messages in both graphical and numerical form for the Drager ventilators Savina, Evita 2 dura and Evita 4.
VentView - a PC programm for displaying ventilation parameters and status messages in both graphical and numerical form for the Drager ventilators Savina, Evita 2 dura and Evita 4.
I am sorry, but the provided text only contains an FDA 510(k) clearance letter for the "VentView" device. This letter indicates that the device has received marketing clearance but does not include information about acceptance criteria, specific studies, or performance data to answer your request.
To provide that information, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a detailed technical specification for the VentView device.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).