510(k) K203210

Invacare Platinum 5NXG Oxygen Concentrator by Invacare Corporation — Product Code CAW

K203210 is an FDA 510(k) premarket notification submitted by Invacare Corporation for the device "Invacare Platinum 5NXG Oxygen Concentrator". The FDA issued a decision of Substantially Equivalent on April 12, 2021. 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.