510(k) K903186

OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE by Telectronics Pacing Systems, Inc. — Product Code DXY

K903186 is an FDA 510(k) premarket notification submitted by Telectronics Pacing Systems, Inc. for the device "OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE". The FDA issued a decision of Substantially Equivalent on January 18, 1991. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Telectronics Pacing Systems, Inc. has at least 10 other 510(k) clearances on record.