CALDYNE, INC. EXHALOMETER EX100, MODEL EX100

CALDYNE, INC. EXHALOMETER EX100, MODEL EX100 is an FDA 510(k)-cleared medical device (K051279) manufactured by Caldyne, 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 September 6, 2005. Regulation: 8.