ZEISS INFRARED 800 WITH FLOW 800 OPTION

ZEISS INFRARED 800 WITH FLOW 800 OPTION is an FDA 510(k)-cleared medical device (K100468) manufactured by Carl Zeiss Surgical GmbH. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 2, 2010. Regulation: 8.