510(k) K031387

ISOLETTE INFANT INCUBATOR, MODEL C2000E by Hill-Rom Manufacturing, Inc. — Product Code FMZ

K031387 is an FDA 510(k) premarket notification submitted by Hill-Rom Manufacturing, Inc. for the device "ISOLETTE INFANT INCUBATOR, MODEL C2000E". The FDA issued a decision of Substantially Equivalent on August 1, 2003. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Hill-Rom Manufacturing, Inc. has at least 3 other 510(k) clearances on record.