EDENTEC MODEL 2000W SYSTEM 700 MONITOR

EDENTEC MODEL 2000W SYSTEM 700 MONITOR is an FDA 510(k)-cleared medical device (K901060) manufactured by Edentec Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 14, 1990. Regulation: 8.