510(k) K884133

PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP by Preemicare Corp. — Product Code LBI

K884133 is an FDA 510(k) premarket notification submitted by Preemicare Corp. for the device "PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP". The FDA issued a decision of Substantially Equivalent on March 8, 1989. The device falls under product code LBI (Unit, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700. Preemicare Corp. has at least 8 other 510(k) clearances on record.