AERO-GEN NEBULIZER

AERO-GEN NEBULIZER is an FDA 510(k)-cleared medical device (K904716) 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 January 1, 1991. Regulation: 8.