510(k) K854790

CERYX PACEMAKER MODELS 114, 314 & 614 by Vitatron Medical BV — Product Code DXY

K854790 is an FDA 510(k) premarket notification submitted by Vitatron Medical BV for the device "CERYX PACEMAKER MODELS 114, 314 & 614". The FDA issued a decision of Substantially Equivalent on August 28, 1986. 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.