510(k) K182199

NFC-700 non-mydriatic auto fundus camera by Crystalvue Medical Corporation — Product Code HKI

K182199 is an FDA 510(k) premarket notification submitted by Crystalvue Medical Corporation for the device "NFC-700 non-mydriatic auto fundus camera". The FDA issued a decision of Substantially Equivalent on January 2, 2019. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Crystalvue Medical Corporation has at least 2 other 510(k) clearances on record.