510(k) K090697

MODIFICATION TO: GIRAFFE AND PANDA WARMER by Ohmeda Medical — Product Code FMT

K090697 is an FDA 510(k) premarket notification submitted by Ohmeda Medical for the device "MODIFICATION TO: GIRAFFE AND PANDA WARMER". The FDA issued a decision of Substantially Equivalent on April 16, 2009. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. Ohmeda Medical has at least 10 other 510(k) clearances on record.