SIMEX SUBGLOTTIC ASPIRATION SYSTEM

SIMEX SUBGLOTTIC ASPIRATION SYSTEM is an FDA 510(k)-cleared medical device (K141255) manufactured by Simex Medizintechnik GmbH. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 21, 2014. Regulation: 8.