510(k) K903378

MODEL C286 ISOLETTE INFANT INCUBATOR by Air-Shields Vickers, Inc. — Product Code FMZ

K903378 is an FDA 510(k) premarket notification submitted by Air-Shields Vickers, Inc. for the device "MODEL C286 ISOLETTE INFANT INCUBATOR". The FDA issued a decision of Substantially Equivalent on October 15, 1990. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Air-Shields Vickers, Inc. has at least 8 other 510(k) clearances on record.