510(k) K813238

NEOCARE BABY-CONTROLLED INCUBATOR by Vickers America Medical Corp. — Product Code FMZ

K813238 is an FDA 510(k) premarket notification submitted by Vickers America Medical Corp. for the device "NEOCARE BABY-CONTROLLED INCUBATOR". The FDA issued a decision of Substantially Equivalent on January 22, 1982. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Vickers America Medical Corp. has at least 10 other 510(k) clearances on record.