BERACLAMP, MODEL BC-1

BERACLAMP, MODEL BC-1 is an FDA 510(k)-cleared medical device (K990045) manufactured by Poamax LLC. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 23, 1999. Regulation: 8.