AEROTEE, MODEL # 1001

AEROTEE, MODEL # 1001 is an FDA 510(k)-cleared medical device (K982408) manufactured by Piper Medical Products. 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 13, 1998. Regulation: 8.