VOLDYNE VOLUMETRIC INCENTIVE DEEP BR. EX

VOLDYNE VOLUMETRIC INCENTIVE DEEP BR. EX is an FDA 510(k)-cleared medical device (K801199) manufactured by Chesebrough-Pond'S U.S.A. Co.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 3, 1980. Regulation: 8.