ASTRAGUARD PULMONARY FUNCTION FILTER

ASTRAGUARD PULMONARY FUNCTION FILTER is an FDA 510(k)-cleared medical device (K062913) manufactured by Sdi Diagnostics, Inc.. 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 25, 2007. Regulation: 8.