BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM

BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM is an FDA 510(k)-cleared medical device (K040068) manufactured by Ohmeda Medical. 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 April 15, 2004. Regulation: 8.