TOMEY EM-1000 SPECULAR MICROSCOPE

TOMEY EM-1000 SPECULAR MICROSCOPE is an FDA 510(k)-cleared medical device (K944910) manufactured by Tomey Corporation USA. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 21, 1994. Regulation: 8.