510(k) K893611

BARD PLAQUE ELECTRODE ARRAY by Bard Electrophysiology — Product Code DRF

K893611 is an FDA 510(k) premarket notification submitted by Bard Electrophysiology for the device "BARD PLAQUE ELECTRODE ARRAY". The FDA issued a decision of Substantially Equivalent on July 14, 1989. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. Bard Electrophysiology has at least 2 other 510(k) clearances on record.