PARAGON 420, CARDIAC MONITOR

PARAGON 420, CARDIAC MONITOR is an FDA 510(k)-cleared medical device (K861067) manufactured by Life Sensing Instrument Company, 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 June 4, 1986. Regulation: 8.