ERA 3000 PACING SYSTEM ANALYZER

ERA 3000 PACING SYSTEM ANALYZER is an FDA 510(k)-cleared medical device (K042708) manufactured by Biotronik, 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 19, 2004. Regulation: 8.