TROPICAIR CONVECTIVE WARING SYSTEM

TROPICAIR CONVECTIVE WARING SYSTEM is an FDA 510(k)-cleared medical device (K946196) manufactured by Seabrook Medical Systems, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 5, 1995. Regulation: 8.