510(k) K083674

PK-141 PATIENT CABLE by Biotronik, Inc. — Product Code DTC

K083674 is an FDA 510(k) premarket notification submitted by Biotronik, Inc. for the device "PK-141 PATIENT CABLE". The FDA issued a decision of Substantially Equivalent on April 1, 2009. The device falls under product code DTC (Analyzer, Pacemaker Generator Function), a Class II device regulated under 21 CFR 870.3630. Biotronik, Inc. has at least 10 other 510(k) clearances on record.