MODIFICATION TO TRANSPORT INCUBATOR 185

MODIFICATION TO TRANSPORT INCUBATOR 185 is an FDA 510(k)-cleared medical device (K031096) manufactured by International Biomedics, 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 June 23, 2003. Regulation: 8.