510(k) K162991

YELLOW 560 Fluorescence Module by Carl Zeiss Meditec, AG — Product Code IZI

K162991 is an FDA 510(k) premarket notification submitted by Carl Zeiss Meditec, AG for the device "YELLOW 560 Fluorescence Module". The FDA issued a decision of Substantially Equivalent (with conditions) on Jul 24, 2017. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Carl Zeiss Meditec, AG has at least 10 other 510(k) clearances on record.