510(k) K882391

OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024 by Ela Medical, Inc. — Product Code DXY

K882391 is an FDA 510(k) premarket notification submitted by Ela Medical, Inc. for the device "OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024". The FDA issued a decision of Substantially Equivalent on November 14, 1988. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Ela Medical, Inc. has at least 10 other 510(k) clearances on record.