LIFEBRIDGE B2T, MODEL 7001

LIFEBRIDGE B2T, MODEL 7001 is an FDA 510(k)-cleared medical device (K090006) manufactured by Lifebridge Medizintechnik AG. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 14, 2009. Regulation: 8.