510(k) K912909

SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM by Air-Shields Vickers, Inc. — Product Code FMZ

K912909 is an FDA 510(k) premarket notification submitted by Air-Shields Vickers, Inc. for the device "SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM". The FDA issued a decision of Substantially Equivalent on November 5, 1991. 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.