MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON

MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON is an FDA 510(k)-cleared medical device (K905575) manufactured by Edentec Corp.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 19, 1991. Regulation: 8.