510(k) K912910

C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEM by Air-Shields Vickers, Inc. — Product Code FMZ

K912910 is an FDA 510(k) premarket notification submitted by Air-Shields Vickers, Inc. for the device "C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEM". The FDA issued a decision of Substantially Equivalent on October 30, 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.