510(k) K973533

NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF) by Nidek, Inc. — Product Code HKI

K973533 is an FDA 510(k) premarket notification submitted by Nidek, Inc. for the device "NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)". The FDA issued a decision of Substantially Equivalent on November 4, 1997. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Nidek, Inc. has at least 10 other 510(k) clearances on record.