FDAnews
www.fdanews.com/articles/73869-china-approves-cardiac-science-powerheart-aeds

CHINA APPROVES CARDIAC SCIENCE POWERHEART AEDS

June 29, 2005

Cardiac Science has received regulatory approval from the People's Republic of China State Food and Drug Administration (SFDA) to sell its latest line of automatic external defibrillators (AEDs), including its Powerheart brand public-access AEDs and the Powerheart CRM, a bedside monitor that automatically treats hospitalized cardiac patients who suffer life-threatening heart rhythms.

The SFDA action provides clearance for Cardiac Science to begin shipments of its G3 series AEDs into China under its Powerheart and FirstSave brands -- as well as under GE Healthcare's Responder brand name, which Cardiac Science manufactures on a private label basis for GE.

The company's branded AEDs operate in the Chinese language and are sold through its local Chinese distribution partners. The GE Responder brand AEDs are marketed in China by GE Healthcare.