DOFI RASTER-SCREEN

DOFI RASTER-SCREEN is an FDA 510(k)-cleared medical device (K943554) manufactured by Howrey & Simon. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 28, 1995. Regulation: 8.