FOLEY CATHETERS WITH TEMPERATURE PROBE

FOLEY CATHETERS WITH TEMPERATURE PROBE is an FDA 510(k)-cleared medical device (K061918) manufactured by GE Healthcare. 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 17, 2006. Regulation: 8.