510(k) K132172

NEONATALIE RESUSCITATOR by Laerdal Medical A/S — Product Code BTM

K132172 is an FDA 510(k) premarket notification submitted by Laerdal Medical A/S for the device "NEONATALIE RESUSCITATOR". The FDA issued a decision of Substantially Equivalent on January 15, 2015. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Laerdal Medical A/S has at least 10 other 510(k) clearances on record.