CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM

CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM is an FDA 510(k)-cleared medical device (K981697) manufactured by Cambridge Heart, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 13, 1998. Regulation: 8.