510(k) K042742

HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM) by Heidelberg Engineering — Product Code MXK

K042742 is an FDA 510(k) premarket notification submitted by Heidelberg Engineering for the device "HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)". The FDA issued a decision of Substantially Equivalent on October 13, 2004. The device falls under product code MXK (Device, Analysis, Anterior Segment), a Class II device regulated under 21 CFR 886.1850. Heidelberg Engineering has at least 10 other 510(k) clearances on record.