EASYONE PRO RESPIRATORY TESTING DEVICE

EASYONE PRO RESPIRATORY TESTING DEVICE is an FDA 510(k)-cleared medical device (K120635) 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 September 26, 2012. Regulation: 8.