510(k) K895782

NEONATAL INCUBATOR (ACCESSORY) by Air-Shields Vickers, Inc. — Product Code FMZ

K895782 is an FDA 510(k) premarket notification submitted by Air-Shields Vickers, Inc. for the device "NEONATAL INCUBATOR (ACCESSORY)". The FDA issued a decision of Substantially Equivalent on December 7, 1989. 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.