VENOUS RESERVOIR BAG BMR-1600

VENOUS RESERVOIR BAG BMR-1600 is an FDA 510(k)-cleared medical device (K851376) manufactured by American Bentley. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 24, 1985. Regulation: 8.