FDAnews
FDAnews Device Daily Bulletin

FDA GRANTS FDA 510(K) REGULATORY CLEARANCE TO CARDIAC SCIENCE FOR NEW ELECTROCARDIOGRAPH

April 27, 2006

The FDA has granted Cardiac Science Corporation, a global leader in advanced cardiac monitoring and external defibrillation products, 510(k) regulatory clearance to market a new resting electrocardiograph, the Atria 6100, the company announced.

The device incorporates state-of-the-art technology to streamline clinical workflow and generate timely, high-quality, accurate electrocardiogram (ECG) results, the company said. Cardiac Science expects to begin shipping the Atria 6100 to customers this quarter.

Cardiac Science provides a comprehensive line of electrocardiographs, which measure the electrical signals representing the rhythm of the heart at rest. The Atria 6100 is designed for use in physician's offices and hospitals, and will be marketed under both the Burdick and Quinton brands, the company said. The device includes traditional features as well as advanced communications and storage features.