510(k) K113111

CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION by Inovo, Inc. — Product Code NFB

K113111 is an FDA 510(k) premarket notification submitted by Inovo, Inc. for the device "CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION". The FDA issued a decision of Substantially Equivalent on December 8, 2011. The device falls under product code NFB (Conserver, Oxygen), a Class II device regulated under 21 CFR 868.5905. Inovo, Inc. has at least 5 other 510(k) clearances on record.