BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM

BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM is an FDA 510(k)-cleared medical device (K011312) manufactured by Khrunichev State Research & Production Space Centr. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 17, 2001. Regulation: 8.