510(k) K791921

CARDIAC PACEMAKER C4000, C1000 SER. by Vitatron Medical BV — Product Code DXY

K791921 is an FDA 510(k) premarket notification submitted by Vitatron Medical BV for the device "CARDIAC PACEMAKER C4000, C1000 SER.". The FDA issued a decision of Substantially Equivalent on October 26, 1979. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Vitatron Medical BV has at least 10 other 510(k) clearances on record.