AERO-GEN NUBULIZER SYSTEM

AERO-GEN NUBULIZER SYSTEM is an FDA 510(k)-cleared medical device (K904718) manufactured by Tri/Bor Medical, 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 31, 1991. Regulation: 8.