TRANSCOM COLON HYDROTHERAPY MODEL HC-2000

TRANSCOM COLON HYDROTHERAPY MODEL HC-2000 is an FDA 510(k)-cleared medical device (K970482) manufactured by Srs Intl.. 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 30, 1997. Regulation: 8.