FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE

FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE is an FDA 510(k)-cleared medical device (K961974) manufactured by Pentax Precision Instrument Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 9, 1997. Regulation: 8.