VENTI-GENTLE-HALER(TM)

VENTI-GENTLE-HALER(TM) is an FDA 510(k)-cleared medical device (K933915) manufactured by Vortran Medical Technology 1, 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 October 27, 1993. Regulation: 8.