(392 days)
The Galileo Ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients. The Galileo ventilator is intended for use where patient care is provided in the hospital and institutional environment. It is not intended for transport outside by health care professional environment or for home use.
Not Found
This document does not contain information about acceptance criteria or a study that proves a device meets such criteria. It is a letter from the FDA to Hamilton Medical, Inc. regarding the 510(k) premarket notification for the Hamilton Medical Galileo Ventilator.
The letter states that the device has been found substantially equivalent to legally marketed predicate devices and outlines the regulatory framework for marketing the device. It also includes an "Indications for Use" statement for the Galileo Ventilator.
Therefore, I cannot provide the requested information based on the input text.
§ 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).