510(k) K102047

LCI OPTION FOR INNOCOR by Innovision A/S — Product Code BZC

K102047 is an FDA 510(k) premarket notification submitted by Innovision A/S for the device "LCI OPTION FOR INNOCOR". The FDA issued a decision of Substantially Equivalent on November 1, 2011. The device falls under product code BZC (Calculator, Pulmonary Function Data), a Class II device regulated under 21 CFR 868.1880. Innovision A/S has at least 9 other 510(k) clearances on record.