510(k) K881808

EMERSON CHEST RESPIRATOR, MODEL 33-CRE by J. H. Emerson Co. — Product Code BYT

K881808 is an FDA 510(k) premarket notification submitted by J. H. Emerson Co. for the device "EMERSON CHEST RESPIRATOR, MODEL 33-CRE". The FDA issued a decision of Substantially Equivalent on August 4, 1988. The device falls under product code BYT (Ventilator, External Body, Negative Pressure, Adult (Cuirass)), a Class II device regulated under 21 CFR 868.5935. J. H. Emerson Co. has at least 10 other 510(k) clearances on record.