510(k) K014274

NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000 by Nidek, Inc. — Product Code HKI

K014274 is an FDA 510(k) premarket notification submitted by Nidek, Inc. for the device "NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000". The FDA issued a decision of Substantially Equivalent on April 17, 2002. 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.