Hudson RCI Voldyne Volumetric Exerciser

Hudson RCI Voldyne Volumetric Exerciser is an FDA 510(k)-cleared medical device (K182847) manufactured by Teleflexmedical, 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 June 30, 2019. Regulation: 8.