510(k) K103589

NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM by Natus Medical Incorporated — Product Code LBI

K103589 is an FDA 510(k) premarket notification submitted by Natus Medical Incorporated for the device "NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on May 13, 2011. The device falls under product code LBI (Unit, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700. Natus Medical Incorporated has at least 9 other 510(k) clearances on record.