510(k) K040068

BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM by Ohmeda Medical — Product Code FMZ

K040068 is an FDA 510(k) premarket notification submitted by Ohmeda Medical for the device "BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on April 16, 2004. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Ohmeda Medical has at least 10 other 510(k) clearances on record.