510(k) K152809

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

K152809 is an FDA 510(k) premarket notification submitted by Ohmeda Medical, A Division of Datex-Ohmeda, Inc. for the device "Giraffe Incubator Carestation CS1". The FDA issued a decision of Substantially Equivalent on December 31, 2015. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Ohmeda Medical, A Division of Datex-Ohmeda, Inc. has at least 2 other 510(k) clearances on record.