ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR

ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR is an FDA 510(k)-cleared medical device (K972371) manufactured by Brasamerica Medical Equipment, 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 August 18, 1997. Regulation: 8.