PNEUMO DRAIN T.M. RECORDER #PD-800

PNEUMO DRAIN T.M. RECORDER #PD-800 is an FDA 510(k)-cleared medical device (K821160) manufactured by Sugen Industries, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 26, 1982. Regulation: 8.