3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS

3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS is an FDA 510(k)-cleared medical device (K022287) manufactured by 3t Medical Systems, LLC. 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 September 22, 2002. Regulation: 8.