NEOBLUE COZY LED PHOTOTHERAPY SYSTEM

NEOBLUE COZY LED PHOTOTHERAPY SYSTEM is an FDA 510(k)-cleared medical device (K051869) manufactured by Natus Medical, 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 October 6, 2005. Regulation: 8.