
Thermasolutions, Inc.
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THERMOCHEM HT-2000 is an FDA 510(k)-cleared medical device (K131583) manufactured by Thermasolutions, Inc.. 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 2, 2013. Regulation: 8.