SORIN MONOLYRH INTEGRATED MEMBRANE LUNG

SORIN MONOLYRH INTEGRATED MEMBRANE LUNG is an FDA 510(k)-cleared medical device (K922933) manufactured by Sorin Biomedica, Fiat, USA, 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 November 29, 1992. Regulation: 8.