VARIABLE HIGH FLOW DOWNS CPAP GENERATOR

VARIABLE HIGH FLOW DOWNS CPAP GENERATOR is an FDA 510(k)-cleared medical device (K861104) manufactured by Med Air Technology, 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 April 27, 1986. Regulation: 8.