510(k) K902764

EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM by J. H. Emerson Co. — Product Code BYT

K902764 is an FDA 510(k) premarket notification submitted by J. H. Emerson Co. for the device "EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM". The FDA issued a decision of Substantially Equivalent on November 19, 1990. 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.