510(k) K772010

CARDIAC PACEMAKER C2001 by Vitatron Medical BV — Product Code DXY

K772010 is an FDA 510(k) premarket notification submitted by Vitatron Medical BV for the device "CARDIAC PACEMAKER C2001". The FDA issued a decision of Substantially Equivalent on November 28, 1977. 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.