510(k) K860921

NEOS VS-1, PULSE GENERATOR by Biotronik Sales, Inc. — Product Code DXY

K860921 is an FDA 510(k) premarket notification submitted by Biotronik Sales, Inc. for the device "NEOS VS-1, PULSE GENERATOR". The FDA issued a decision of Substantially Equivalent on August 8, 1986. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Biotronik Sales, Inc. has at least 10 other 510(k) clearances on record.