OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED

OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED is an FDA 510(k)-cleared medical device (K923348) 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 December 9, 1992. Regulation: 8.