510(k) K023205

ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP by Biotronik, Inc. — Product Code DTB

K023205 is an FDA 510(k) premarket notification submitted by Biotronik, Inc. for the device "ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP". The FDA issued a decision of ST on April 24, 2003. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Biotronik, Inc. has at least 10 other 510(k) clearances on record.