510(k) K033613

MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER by Biotronik, Inc. — Product Code DTA

K033613 is an FDA 510(k) premarket notification submitted by Biotronik, Inc. for the device "MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER". The FDA issued a decision of Substantially Equivalent on December 8, 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.