DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE

DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE is an FDA 510(k)-cleared medical device (K923211) manufactured by Zeiss Humphrey System. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 7, 1993. Regulation: 8.