SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)

SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW) is an FDA 510(k)-cleared medical device (K113542) manufactured by Salter Labs, Arvin Facility. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 9, 2012. Regulation: 8.