BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE

BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE is an FDA 510(k)-cleared medical device (K091461) manufactured by Cardiopulmonary Corp.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 13, 2009. Regulation: 8.