
Biotronik, Inc.
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ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP is an FDA 510(k)-cleared medical device (K023205) 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 April 23, 2003. Regulation: 8.