510(k) K781168

GENERATOR, PULSE, PACEMAKER by Vitatron Medical BV — Product Code DXY

K781168 is an FDA 510(k) premarket notification submitted by Vitatron Medical BV for the device "GENERATOR, PULSE, PACEMAKER". The FDA issued a decision of Substantially Equivalent on August 31, 1978. 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.