EASYONE PRO RESPIRATORY ANALYSIS SYSTEM

EASYONE PRO RESPIRATORY ANALYSIS SYSTEM is an FDA 510(k)-cleared medical device (K091428) manufactured by Ndd Medizitechnik AG. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 26, 2010. Regulation: 8.