510(k) K152814

Giraffe OmniBed Carestation CS1 by Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company — Product Code FMZ

K152814 is an FDA 510(k) premarket notification submitted by Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company for the device "Giraffe OmniBed Carestation CS1". The FDA issued a decision of Substantially Equivalent on March 17, 2016. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400.