510(k) K941106

MODEL TI500 ISOLETTE INFANT INCUBATOR by Air-Shields, Inc. — Product Code FPL

K941106 is an FDA 510(k) premarket notification submitted by Air-Shields, Inc. for the device "MODEL TI500 ISOLETTE INFANT INCUBATOR". The FDA issued a decision of Substantially Equivalent on June 10, 1994. The device falls under product code FPL (Incubator, Neonatal Transport), a Class II device regulated under 21 CFR 880.5410. Air-Shields, Inc. has at least 10 other 510(k) clearances on record.