STOCKERTIR PURGE CONTROL (APC) SYSTEM

STOCKERTIR PURGE CONTROL (APC) SYSTEM is an FDA 510(k)-cleared medical device (K041558) manufactured by Stockert Instrumente GmbH. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 1, 2004. Regulation: 8.