DreamStation 2 System, DreamStation 2 Advanced System

DreamStation 2 System, DreamStation 2 Advanced System is an FDA 510(k)-cleared medical device (K200480) manufactured by Respironics, 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 July 9, 2020. Regulation: 8.