510(k) K862226

DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS by Pacesetter Systems — Product Code DXY

K862226 is an FDA 510(k) premarket notification submitted by Pacesetter Systems for the device "DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS". The FDA issued a decision of Substantially Equivalent on February 3, 1987. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Pacesetter Systems has at least 10 other 510(k) clearances on record.