GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS

GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS is an FDA 510(k)-cleared medical device (K915154) manufactured by C.G.H. Medical, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 26, 1992. Regulation: 8.