510(k) K895916

PE INTERCARDIAC MAPPING SYSTEM (ICMS) by Prucka Engineering, Inc. — Product Code DRF

K895916 is an FDA 510(k) premarket notification submitted by Prucka Engineering, Inc. for the device "PE INTERCARDIAC MAPPING SYSTEM (ICMS)". The FDA issued a decision of Substantially Equivalent on December 13, 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. Prucka Engineering, Inc. has at least 5 other 510(k) clearances on record.