ABIOMED BODY LEAD ANALYZER MODEL 200/20

ABIOMED BODY LEAD ANALYZER MODEL 200/20 is an FDA 510(k)-cleared medical device (K900574) manufactured by Abiomed, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 14, 1990. Regulation: 8.