FULL-DISCLOSURE AMBULATORY ECG SYSTEM

FULL-DISCLOSURE AMBULATORY ECG SYSTEM is an FDA 510(k)-cleared medical device (K823529) manufactured by Clinical Data, 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 December 14, 1982. Regulation: 8.