510(k) K040853

PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101 by International Hospital Supply Co. — Product Code LBI

K040853 is an FDA 510(k) premarket notification submitted by International Hospital Supply Co. for the device "PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101". The FDA issued a decision of Substantially Equivalent on Jun 21, 2004. The device falls under product code LBI (Unit, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700. International Hospital Supply Co. has at least 4 other 510(k) clearances on record.