
Ndd Medizitechnik AG
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EASY ON-PC SPIROMETER is an FDA 510(k)-cleared medical device (K090034) 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 June 1, 2009. Regulation: 8.