510(k) K163021

HAAG-STREIT FUNDUS MODULE 300 by Optomed OY — Product Code HKI

K163021 is an FDA 510(k) premarket notification submitted by Optomed OY for the device "HAAG-STREIT FUNDUS MODULE 300". The FDA issued a decision of Substantially Equivalent on April 11, 2017. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Optomed OY has at least 7 other 510(k) clearances on record.