510(k) K051540

INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR by Inovo, Inc. — Product Code NFB

K051540 is an FDA 510(k) premarket notification submitted by Inovo, Inc. for the device "INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR". The FDA issued a decision of Substantially Equivalent on September 21, 2005. 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.