510(k) K915159

PEDIATRIC MULTI-FUNCTION ELECTRODES by Zmi Corp. — Product Code DRF

K915159 is an FDA 510(k) premarket notification submitted by Zmi Corp. for the device "PEDIATRIC MULTI-FUNCTION ELECTRODES". The FDA issued a decision of Substantially Equivalent on February 7, 1992. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. Zmi Corp. has at least 7 other 510(k) clearances on record.