510(k) K904747

PEI PLAQUE ELECTRODE ARRAY by Prucka Engineering, Inc. — Product Code DRF

K904747 is an FDA 510(k) premarket notification submitted by Prucka Engineering, Inc. for the device "PEI PLAQUE ELECTRODE ARRAY". The FDA issued a decision of Substantially Equivalent on October 9, 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. Prucka Engineering, Inc. has at least 5 other 510(k) clearances on record.