XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP

XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP is an FDA 510(k)-cleared medical device (K022384) manufactured by Isolux America. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 17, 2002. Regulation: 8.