CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800

CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800 is an FDA 510(k)-cleared medical device (K992703) manufactured by Premier Heart, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 20, 2000. Regulation: 8.