510(k) K102824

AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC by Ambu A/S — Product Code BTM

K102824 is an FDA 510(k) premarket notification submitted by Ambu A/S for the device "AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC". The FDA issued a decision of Substantially Equivalent on January 28, 2011. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Ambu A/S has at least 10 other 510(k) clearances on record.