510(k) K945540

CAAS II by Pie Medical Equipment B.V. — Product Code IZI

K945540 is an FDA 510(k) premarket notification submitted by Pie Medical Equipment B.V. for the device "CAAS II". The FDA issued a decision of Substantially Equivalent on June 28, 1995. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Pie Medical Equipment B.V. has at least 7 other 510(k) clearances on record.