OMNIGRAPH 4000(ELECTROCARDIOGRAPH)

OMNIGRAPH 4000(ELECTROCARDIOGRAPH) is an FDA 510(k)-cleared medical device (K852652) manufactured by Telemed Div.. 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 18, 1985. Regulation: 8.