510(k) K905831

ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH by Arzco Medical Electronics, Inc. — Product Code DRF

K905831 is an FDA 510(k) premarket notification submitted by Arzco Medical Electronics, Inc. for the device "ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH". The FDA issued a decision of Substantially Equivalent on March 29, 1991. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. Arzco Medical Electronics, Inc. has at least 2 other 510(k) clearances on record.