510(k) K182178

neoBLUE blanket LED Phototherapy System by Natus Medical Incorporated — Product Code LBI

K182178 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 December 13, 2018. 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.