NICKI, MODEL NUMBER USD-NK-UP1

NICKI, MODEL NUMBER USD-NK-UP1 is an FDA 510(k)-cleared medical device (K924086) manufactured by Laborie Medical Technologies, Ltd.. 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 October 19, 1992. Regulation: 8.