www.fdanews.com/articles/202463-getinge-earns-510k-clearance-for-magnetic-resonance-ventilator
Getinge Earns 510(k) Clearance for Magnetic Resonance Ventilator
April 23, 2021
Getinge has received the FDA’s 510(k) clearance for Servo-u MR, a conditional ventilator designed for use during magnetic resonance (MR) scanning.
The device provides both noninvasive and invasive ventilation, as well as high-flow oxygen therapy while MR scans are in progress.
The device, which supports all age groups, including neonates, features a magnetic field indicator that guides it into a safe position and provides visual and audible alerts.