
Biotronik, Inc.
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ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668 is an FDA 510(k)-cleared medical device (K001413) manufactured by Biotronik, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on June 1, 2000. Regulation: 8.