LMA FASTRACH ETT SINGLE USE

LMA FASTRACH ETT SINGLE USE is an FDA 510(k)-cleared medical device (K051993) manufactured by The Laryngeal Mask Co., Ltd.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 12, 2005. Regulation: 8.