510(k) K850596

PACE*AID 10 A -PAD 10A- PACEMAKER OUTPUT DISPLAY & by Cardiac Resucitator Corp. — Product Code DRO

K850596 is an FDA 510(k) premarket notification submitted by Cardiac Resucitator Corp. for the device "PACE*AID 10 A -PAD 10A- PACEMAKER OUTPUT DISPLAY &". The FDA issued a decision of Substantially Equivalent on March 6, 1985. The device falls under product code DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)), a Class II device regulated under 21 CFR 870.5550. Cardiac Resucitator Corp. has at least 10 other 510(k) clearances on record.