510(k) K070247

GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM by Ohmeda Medical — Product Code BTM

K070247 is an FDA 510(k) premarket notification submitted by Ohmeda Medical for the device "GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM". The FDA issued a decision of Substantially Equivalent on April 20, 2007. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Ohmeda Medical has at least 10 other 510(k) clearances on record.