QUADROX-IR ADULT AND SMALL ADULT

QUADROX-IR ADULT AND SMALL ADULT is an FDA 510(k)-cleared medical device (K133265) manufactured by Maquet Cardiopulmonary, AG. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 11, 2013. Regulation: 8.