510(k) K950091

KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000 by Konan Medical, Inc. — Product Code HKI

K950091 is an FDA 510(k) premarket notification submitted by Konan Medical, Inc. for the device "KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000". The FDA issued a decision of Substantially Equivalent on March 1, 1995. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Konan Medical, Inc. has at least 6 other 510(k) clearances on record.