TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR*

TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR* is an FDA 510(k)-cleared medical device (K864835) manufactured by Eisai U.S.A., Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 10, 1987. Regulation: 8.