www.fdanews.com/articles/197990-getinge-gets-510k-clearance-for-mechanical-ventilator
Getinge Gets 510(k) Clearance for Mechanical Ventilator
July 9, 2020
Getinge has received 510(k) clearance from the FDA for its Servo-air mechanical ventilator, a critical care ventilator for pediatric and adult patients.
The battery-powered unit can provide both invasive and non-invasive ventilation options and it includes an automated ventilation mode that helps patients transition to normal breathing.
The unit also tracks patient ventilation over 72-hours, allowing healthcare providers to assess trends and determine the best follow-up care.