510(k) K022360

ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP. by Biotronik, Inc. — Product Code DTA

K022360 is an FDA 510(k) premarket notification submitted by Biotronik, Inc. for the device "ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP.". The FDA issued a decision of Substantially Equivalent on January 27, 2003. The device falls under product code DTA (Tester, Pacemaker Electrode Function), a Class II device regulated under 21 CFR 870.3720. Biotronik, Inc. has at least 10 other 510(k) clearances on record.