510(k) K073230

MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS by Biotronik, Inc. — Product Code DTA

K073230 is an FDA 510(k) premarket notification submitted by Biotronik, Inc. for the device "MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS". The FDA issued a decision of Substantially Equivalent on December 20, 2007. 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.