510(k) K952363

OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) by Ela Medical, Inc. — Product Code ELA

K952363 is an FDA 510(k) premarket notification submitted by Ela Medical, Inc. for the device "OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)". The FDA issued a decision of Substantially Equivalent on August 15, 1995. The device falls under product code ELA (Instrument, Hand, Calculus Removal), a Class I device regulated under 21 CFR 872.4565. Ela Medical, Inc. has at least 10 other 510(k) clearances on record.