510(k) K895849

RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM by Respironics, Inc. — Product Code BYT

K895849 is an FDA 510(k) premarket notification submitted by Respironics, Inc. for the device "RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM". The FDA issued a decision of Substantially Equivalent on December 22, 1989. The device falls under product code BYT (Ventilator, External Body, Negative Pressure, Adult (Cuirass)), a Class II device regulated under 21 CFR 868.5935. Respironics, Inc. has at least 10 other 510(k) clearances on record.