510(k) K913291

MODEL C386 ISOLETTE(R) INFANT INCUBATOR by Air-Shields, Inc. — Product Code FMZ

K913291 is an FDA 510(k) premarket notification submitted by Air-Shields, Inc. for the device "MODEL C386 ISOLETTE(R) INFANT INCUBATOR". The FDA issued a decision of Substantially Equivalent on November 13, 1991. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Air-Shields, Inc. has at least 10 other 510(k) clearances on record.