LIFE SCOPE EC, MODEL BSM-1102

LIFE SCOPE EC, MODEL BSM-1102 is an FDA 510(k)-cleared medical device (K000517) manufactured by Nihon Kohden America, 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 August 30, 2000. Regulation: 8.