S9 VPAP ST WITH H5I

S9 VPAP ST WITH H5I is an FDA 510(k)-cleared medical device (K102513) 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 January 4, 2011. Regulation: 8.