Spacelabs receives FDA 510(k) clearance for Blease900 Ventilator

Spacelabs Healthcare today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for the Blease900 Ventilator - an integral component of its BleaseFocus anesthesia system - paving the way for launch of the new BleaseFocus anesthesia system to healthcare facilities in the United States.

“The new BleaseFocus continues our concentration on providing the best patient care experience and is an important addition to our growing anesthesia product portfolio.”

The Blease900 ventilator introduces Patient Centered Ventilation with advanced modes of ventilation, Precision Pressure Control Ventilation™ and Advanced Pressure Support™, allowing the patient to breathe more comfortably with the ventilator matching patient demand.

Offering a unique blend of innovative design, high performance, versatility and value, the BleaseFocus with Blease900 ventilator is ideal for day surgery centers and smaller hospitals where compact size is also a requirement.

The company is confident that this new solution will be well received by customers in the US market and the many international markets in which it sells. Nicholas Ong, President of Spacelabs Healthcare stated, "The new BleaseFocus continues our concentration on providing the best patient care experience and is an important addition to our growing anesthesia product portfolio."

Spacelabs Healthcare has a long, rich history of innovation in the perioperative area, having produced many "firsts," such as the first anesthesia ventilator to integrate spirometry loops and the first maintenance-free vaporizer. Today, a team of engineers with more than 200 years of combined experience leads the company's perioperative development and research center located in Madison, Wisconsin.

Providing solutions suited to all anesthesia environments, Spacelabs' anesthesia delivery offerings now include BleaseFocus, BleaseSirius, BleaseSirius EFM, and ARKON^TM.