ISOLETTE INFANT INCUBATOR, MODEL C2000E

ISOLETTE INFANT INCUBATOR, MODEL C2000E is an FDA 510(k)-cleared medical device (K031387) manufactured by Hill-Rom Manufacturing, 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 July 31, 2003. Regulation: 8.