510(k) K112852

BABI PLUS NEONATAL RESUSCITATION BAG by A Plus Medical — Product Code BTM

K112852 is an FDA 510(k) premarket notification submitted by A Plus Medical for the device "BABI PLUS NEONATAL RESUSCITATION BAG". The FDA issued a decision of Substantially Equivalent on January 13, 2012. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. A Plus Medical has at least 6 other 510(k) clearances on record.