KOO SMALL VOLUME NEBULIZER (SVN)

KOO SMALL VOLUME NEBULIZER (SVN) is an FDA 510(k)-cleared medical device (K112041) manufactured by Koo (Shanghai) Industries Co., 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 December 21, 2011. Regulation: 8.