CIRCU-FLATE 5000 PRESSURE RELIEF SYSTEM

CIRCU-FLATE 5000 PRESSURE RELIEF SYSTEM is an FDA 510(k)-cleared medical device (K943097) manufactured by Global Medical Technologies, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 22, 1994. Regulation: 8.