NATUS BLUE LIGHT PHOTOTHERAPY UNIT

NATUS BLUE LIGHT PHOTOTHERAPY UNIT is an FDA 510(k)-cleared medical device (K022196) 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 September 18, 2002. Regulation: 8.