510(k) K152931

Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator by Ambu A/S — Product Code BTM

K152931 is an FDA 510(k) premarket notification submitted by Ambu A/S for the device "Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator". The FDA issued a decision of Substantially Equivalent on August 29, 2016. 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.