510(k) K790666

VITALITH S 3000 SERIES by Vitatron Medical BV — Product Code DXY

K790666 is an FDA 510(k) premarket notification submitted by Vitatron Medical BV for the device "VITALITH S 3000 SERIES". The FDA issued a decision of Substantially Equivalent on June 1, 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.