ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AND PU 12300

ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AND PU 12300 is an FDA 510(k)-cleared medical device (K951259) manufactured by Impulso Trading Co.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 19, 1995. Regulation: 8.