510(k) K970072

OPUS S MODEL 4121 AND 4124 PACEMAKERS by Ela Medical, Inc. — Product Code DXY

K970072 is an FDA 510(k) premarket notification submitted by Ela Medical, Inc. for the device "OPUS S MODEL 4121 AND 4124 PACEMAKERS". The FDA issued a decision of ST on August 29, 1997. 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.