510(k) K894065

OPUS MODEL 4001 by Ela Medical, Inc. — Product Code DXY

K894065 is an FDA 510(k) premarket notification submitted by Ela Medical, Inc. for the device "OPUS MODEL 4001". The FDA issued a decision of Substantially Equivalent on September 26, 1989. 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.