3-DAY BIOINDICATOR RELEASE FOR RESPIR

3-DAY BIOINDICATOR RELEASE FOR RESPIR is an FDA 510(k)-cleared medical device (K833832) manufactured by Shiley, 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 March 14, 1984. Regulation: 8.