MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM

MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM is an FDA 510(k)-cleared medical device (K912444) manufactured by Radiometer America, 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 February 17, 1992. Regulation: 8.