D100 COMPUTER CARDIAC ANALYSIS SYSTEM

D100 COMPUTER CARDIAC ANALYSIS SYSTEM is an FDA 510(k)-cleared medical device (K863231) manufactured by Dextra Medical, 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 November 24, 1986. Regulation: 8.