510(k) K051887

PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF) by Carleton Life Support Systems, Inc. — Product Code CAW

K051887 is an FDA 510(k) premarket notification submitted by Carleton Life Support Systems, Inc. for the device "PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF)". The FDA issued a decision of Substantially Equivalent on September 27, 2005. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Carleton Life Support Systems, Inc. has at least 2 other 510(k) clearances on record.