MODEL 6000FD AMBULATORY ECG ANALYSIS SYSTEM

MODEL 6000FD AMBULATORY ECG ANALYSIS SYSTEM is an FDA 510(k)-cleared medical device (K873680) manufactured by Oxford Medilog, 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 22, 1987. Regulation: 8.