510(k) K213551

Giraffe Omnibed Carestation CS1 by Datex Ohmeda, Inc. — Product Code FMT

K213551 is an FDA 510(k) premarket notification submitted by Datex Ohmeda, Inc. for the device "Giraffe Omnibed Carestation CS1". The FDA issued a decision of Substantially Equivalent on March 2, 2022. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. Datex Ohmeda, Inc. has at least 2 other 510(k) clearances on record.