COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET

COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET is an FDA 510(k)-cleared medical device (K974897) manufactured by Cobe Cardiovascular, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 30, 1998. Regulation: 8.