510(k) K974830

ULTRA BILI LIGHT by Physician Engineered Products, Inc. — Product Code LBI

K974830 is an FDA 510(k) premarket notification submitted by Physician Engineered Products, Inc. for the device "ULTRA BILI LIGHT". The FDA issued a decision of Substantially Equivalent on May 20, 1998. The device falls under product code LBI (Unit, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700. Physician Engineered Products, Inc. has at least 7 other 510(k) clearances on record.