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C.R. Bard Inc., Bard Electrophysiology Division
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V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM is an FDA 510(k)-cleared medical device (K113811) manufactured by C.R. Bard Inc., Bard Electrophysiology Division. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 15, 2012. Regulation: 8.