510(k) K881476

PREEMICARE MODEL D1-X1, SERIES 3000 by Preemicare Corp. — Product Code FMZ

K881476 is an FDA 510(k) premarket notification submitted by Preemicare Corp. for the device "PREEMICARE MODEL D1-X1, SERIES 3000". The FDA issued a decision of Substantially Equivalent on December 8, 1988. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Preemicare Corp. has at least 8 other 510(k) clearances on record.