510(k) K200890

Invacare Perfecto2V Oxygen Concentrator by Invacare Corporation — Product Code CAW

K200890 is an FDA 510(k) premarket notification submitted by Invacare Corporation for the device "Invacare Perfecto2V Oxygen Concentrator". The FDA issued a decision of Substantially Equivalent on August 6, 2020. 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.