
Carl Zeiss Meditec, Inc.
Free shipping on orders over $99 · 30-day returns
STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE is an FDA 510(k)-cleared medical device (K033123) 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 April 19, 2004. Regulation: 8.