GDX VCC WITH ECC SOFTWARE

GDX VCC WITH ECC SOFTWARE is an FDA 510(k)-cleared medical device (K082016) manufactured by Carl Zeiss Meditec, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 9, 2009. Regulation: 8.