510(k) K861325

MAXI-USE O2 DEVICE by B & F Medical Products, Inc. — Product Code NFB

K861325 is an FDA 510(k) premarket notification submitted by B & F Medical Products, Inc. for the device "MAXI-USE O2 DEVICE". The FDA issued a decision of Substantially Equivalent on September 9, 1986. The device falls under product code NFB (Conserver, Oxygen), a Class II device regulated under 21 CFR 868.5905. B & F Medical Products, Inc. has at least 10 other 510(k) clearances on record.