510(k) K023099

AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP by Biotronik, Inc. — Product Code DTB

K023099 is an FDA 510(k) premarket notification submitted by Biotronik, Inc. for the device "AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP". The FDA issued a decision of Substantially Equivalent on October 18, 2002. 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.