510(k) K944910

TOMEY EM-1000 SPECULAR MICROSCOPE by Tomey Corporation USA — Product Code HJO

K944910 is an FDA 510(k) premarket notification submitted by Tomey Corporation USA for the device "TOMEY EM-1000 SPECULAR MICROSCOPE". The FDA issued a decision of Substantially Equivalent on November 22, 1994. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Tomey Corporation USA has at least 8 other 510(k) clearances on record.