510(k) K924297

DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER by Air-Shields Vickers, Inc. — Product Code FMZ

K924297 is an FDA 510(k) premarket notification submitted by Air-Shields Vickers, Inc. for the device "DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER". The FDA issued a decision of Substantially Equivalent on March 18, 1993. 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.