510(k) K842487

SAMSON'S NEWBORN LUNG INFLATOR 340-1000 by J. H. Emerson Co. — Product Code BTM

K842487 is an FDA 510(k) premarket notification submitted by J. H. Emerson Co. for the device "SAMSON'S NEWBORN LUNG INFLATOR 340-1000". The FDA issued a decision of Substantially Equivalent on July 6, 1984. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. J. H. Emerson Co. has at least 10 other 510(k) clearances on record.