510(k) K072512

MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) by Datex-Ohmeda, Inc. — Product Code FMZ

K072512 is an FDA 510(k) premarket notification submitted by Datex-Ohmeda, Inc. for the device "MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)". The FDA issued a decision of Substantially Equivalent on October 3, 2007. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Datex-Ohmeda, Inc. has at least 10 other 510(k) clearances on record.