THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER

THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER is an FDA 510(k)-cleared medical device (K972824) manufactured by Pn Medical. 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 2, 1998. Regulation: 8.