ABBOTT AXSYM DIGITOXIN (MODIFY)

ABBOTT AXSYM DIGITOXIN (MODIFY) is an FDA 510(k)-cleared medical device (K963158) manufactured by Abbott Laboratories. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 9, 1996. Regulation: 8.