LungTrainer (MD2 & MD3)

LungTrainer (MD2 & MD3) is an FDA 510(k)-cleared medical device (K221058) manufactured by Lung Trainers, LLC. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 4, 2023. Regulation: 8.