510(k) K910947

NEV-10 NEGATIVE PRESSURE VENTILATOR by Lifecare Services, Inc. — Product Code BYT

K910947 is an FDA 510(k) premarket notification submitted by Lifecare Services, Inc. for the device "NEV-10 NEGATIVE PRESSURE VENTILATOR". The FDA issued a decision of Substantially Equivalent on June 3, 1991. The device falls under product code BYT (Ventilator, External Body, Negative Pressure, Adult (Cuirass)), a Class II device regulated under 21 CFR 868.5935. Lifecare Services, Inc. has at least 10 other 510(k) clearances on record.