510(k) K945511

LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR by Physio-Control Corp. — Product Code MPE

K945511 is an FDA 510(k) premarket notification submitted by Physio-Control Corp. for the device "LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR". The FDA issued a decision of Substantially Equivalent on September 26, 1995. The device falls under product code MPE (Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker), a Class II device regulated under 21 CFR 870.5550. Physio-Control Corp. has at least 10 other 510(k) clearances on record.