ANGEION IGITAL ANGEFLATOR

ANGEION IGITAL ANGEFLATOR is an FDA 510(k)-cleared medical device (K921757) manufactured by Angeion Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 17, 1993. Regulation: 8.