EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS.

EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS. is an FDA 510(k)-cleared medical device (K884614) 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 January 31, 1989. Regulation: 8.