510(k) K083751

INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100 by Invacare Corporation — Product Code CAW

K083751 is an FDA 510(k) premarket notification submitted by Invacare Corporation for the device "INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100". The FDA issued a decision of Substantially Equivalent on May 21, 2009. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Invacare Corporation has at least 10 other 510(k) clearances on record.