510(k) K002598

EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING by J. H. Emerson Co. — Product Code NHJ

K002598 is an FDA 510(k) premarket notification submitted by J. H. Emerson Co. for the device "EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING". The FDA issued a decision of Substantially Equivalent on November 22, 2000. The device falls under product code NHJ (Device, Positive Pressure Breathing, Intermittent), a Class II device regulated under 21 CFR 868.5905. J. H. Emerson Co. has at least 10 other 510(k) clearances on record.