510(k) K020386

INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02 by Invacare Corp. — Product Code CAW

K020386 is an FDA 510(k) premarket notification submitted by Invacare Corp. for the device "INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02". The FDA issued a decision of Substantially Equivalent on July 2, 2002. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Invacare Corp. has at least 10 other 510(k) clearances on record.