510(k) K832176

NEGATIVE PRESSURE CHEST RESPIRATOR PUMP by J. H. Emerson Co. — Product Code BYT

K832176 is an FDA 510(k) premarket notification submitted by J. H. Emerson Co. for the device "NEGATIVE PRESSURE CHEST RESPIRATOR PUMP". The FDA issued a decision of Substantially Equivalent on September 12, 1983. 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.