S8 ASPEN WITH H4I PLUS

S8 ASPEN WITH H4I PLUS is an FDA 510(k)-cleared medical device (K111148) manufactured by Resmed Corp. 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 29, 2011. Regulation: 8.