510(k) K974349

OHMEDA-OHIO CARE PLUS INCUBATOR by Ohmeda Medical — Product Code FMZ

K974349 is an FDA 510(k) premarket notification submitted by Ohmeda Medical for the device "OHMEDA-OHIO CARE PLUS INCUBATOR". The FDA issued a decision of Substantially Equivalent on February 12, 1998. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Ohmeda Medical has at least 10 other 510(k) clearances on record.