510(k) K131196

INFANT PHOTOTHERAPY BILITRON SKY 5006 by Fanem Lda — Product Code LBI

K131196 is an FDA 510(k) premarket notification submitted by Fanem Lda for the device "INFANT PHOTOTHERAPY BILITRON SKY 5006". The FDA issued a decision of Substantially Equivalent on February 20, 2014. The device falls under product code LBI (Unit, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700.