QUALITROL IGAME CONTROLS, LEVELS 1 AND 2

QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 is an FDA 510(k)-cleared medical device (K961544) manufactured by Consolidated Technologies, Inc.. This device is classified under the Immunology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 23, 1996. Regulation: 8.