FIBER OPTIC ENDOSCOPE

FIBER OPTIC ENDOSCOPE is an FDA 510(k)-cleared medical device (K921918) manufactured by Electro Fiberoptics Corp.. 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 August 16, 1993. Regulation: 8.