DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARDIOVERSION

DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARDIOVERSION is an FDA 510(k)-cleared medical device (K921207) manufactured by Physiometrix, Inc.. 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 12, 1992. Regulation: 8.