510(k) K954611

DRAGER PT4000 PHOTOTHERAPY SYSTEM by Drager, Inc. — Product Code LBI

K954611 is an FDA 510(k) premarket notification submitted by Drager, Inc. for the device "DRAGER PT4000 PHOTOTHERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on December 1, 1995. The device falls under product code LBI (Unit, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700. Drager, Inc. has at least 10 other 510(k) clearances on record.