FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR

FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR is an FDA 510(k)-cleared medical device (K070049) manufactured by Fresenius Medical Care North America. 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 2, 2011. Regulation: 8.