510(k) K083157

HS AMICA by H.S Hospital Service S.P.A — Product Code NEY

K083157 is an FDA 510(k) premarket notification submitted by H.S Hospital Service S.P.A for the device "HS AMICA". The FDA issued a decision of Substantially Equivalent on September 29, 2009. The device falls under product code NEY (System, Ablation, Microwave And Accessories), a Class II device regulated under 21 CFR 878.4400. H.S Hospital Service S.P.A has at least 5 other 510(k) clearances on record.