
GE Healthcare
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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.

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