MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS

MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS is an FDA 510(k)-cleared medical device (K073230) 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 19, 2007. Regulation: 8.