MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER

MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER is an FDA 510(k)-cleared medical device (K033613) 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 December 7, 2003. Regulation: 8.