(13 days)
The Venturi® ventilator is intended to mechanically control or assist the breathing of adult and pediatric patients. The Venturi® is designed for use in hospital intensive care units (ICU).
Not Found
I am sorry, but the provided text does not contain information about the acceptance criteria, study details, or performance data for the Venturi® Ventilator. The document is an FDA 510(k) clearance letter from 1999, which primarily states that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use.
Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and the study that proves the device meets them.
§ 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).