C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP

C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP is an FDA 510(k)-cleared medical device (K821328) manufactured by Medionics International , Ltd.. 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 July 27, 1982. Regulation: 8.