RESMED S8 PIONEER CPAP SYSTEM

RESMED S8 PIONEER CPAP SYSTEM is an FDA 510(k)-cleared medical device (K041209) manufactured by Resmed, Ltd.. 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, 2004. Regulation: 8.