Dräger Secures FDA 510(k) Clearance for Evita V600, V800 and Babylog VN800 Ventilators

Dräger announced today that it received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for the Evita V600, V800, and Babylog VN800, its newest devices for mechanical ventilation of adults to premature babies. Dräger has developed an operating concept that makes device orientation easier and provides clear user guidance. The user is guided through the individual menus with larger icons, important functions at the top menu level, and a clear, color-coordinated screen design. The lower number of colors for the screen elements and the reduced use of signal colors enable clear, smooth navigation. The bright screen background also minimizes disruptive reflections of ambient light. Clearly structured device checks help safely prepare for the next patient.

“We developed the Evita and Babylog family of devices to meet customer demand for effective and safe mechanical ventilation that is both easy to use and cost-conscious,” said Steve Menet, Senior Vice President of Sales for Hospital Solutions at Draeger, Inc. “This launch takes us a step closer to our goal of providing added value for clinical personnel and patients while simultaneously optimizing costs in the hospital.”

Proven ventilation technology protects patients

Over one hundred years of Dräger experience in ventilation flowed into the technology. It is the basis for efficient therapy options, which can simultaneously improve patient safety. The early support of spontaneous breathing can also help the patient regain mobility more quickly.

Infection prevention requirements considered

To maintain the infection management chain in the hospital, medical devices must support the requirements of hygienically sensitive areas in hospitals. As a result, the new Dräger ventilators not only have a rounded design with few edges and overhangs, but they also have surfaces that can be effectively disinfected. The glass touchscreen on the devices, as an almost seamless screen, also supports the daily hygiene routine at the intensive care workstation.

The Evita V600, Evita V800, and Babylog VN800 ventilators are manufactured by Drägerwerk AG & Co. KGaA.

SourceDräger

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