HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS

HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS is an FDA 510(k)-cleared medical device (K030515) manufactured by Hans Rudolph, 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 May 1, 2003. Regulation: 8.