CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105

CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105 is an FDA 510(k)-cleared medical device (K090646) manufactured by Chest M.I., 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 July 22, 2009. Regulation: 8.