510(k) K101804

GIRAFFE AND PANDA WARMERS by Ohmeda Medical, A Division of Datex-Ohmeda, Inc. — Product Code FMT

K101804 is an FDA 510(k) premarket notification submitted by Ohmeda Medical, A Division of Datex-Ohmeda, Inc. for the device "GIRAFFE AND PANDA WARMERS". The FDA issued a decision of Substantially Equivalent on July 21, 2010. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. Ohmeda Medical, A Division of Datex-Ohmeda, Inc. has at least 2 other 510(k) clearances on record.