510(k) K897116

OPTIMA MPT MODEL 5281E AND MODEL 5282E by Telectronics Pacing Systems, Inc. — Product Code DXY

K897116 is an FDA 510(k) premarket notification submitted by Telectronics Pacing Systems, Inc. for the device "OPTIMA MPT MODEL 5281E AND MODEL 5282E". The FDA issued a decision of Substantially Equivalent on March 14, 1990. 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.