510(k) K952364

OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) by Ela Medical, Inc. — Product Code DXY

K952364 is an FDA 510(k) premarket notification submitted by Ela Medical, Inc. for the device "OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)". The FDA issued a decision of ST on September 1, 1995. 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.