510(k) K812464

SYNTHEMED PULSE GENERATOR VVI MODEL 1000 by Synthemed Corp. — Product Code DXY

K812464 is an FDA 510(k) premarket notification submitted by Synthemed Corp. for the device "SYNTHEMED PULSE GENERATOR VVI MODEL 1000". The FDA issued a decision of Substantially Equivalent on November 16, 1981. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Synthemed Corp. has at least 1 other 510(k) clearance on record.