510(k) K780558

BOTTLE BREATHING DEVICE by B & F Medical Products, Inc. — Product Code BYO

K780558 is an FDA 510(k) premarket notification submitted by B & F Medical Products, Inc. for the device "BOTTLE BREATHING DEVICE". The FDA issued a decision of Substantially Equivalent on May 26, 1978. The device falls under product code BYO (Bottle, Blow), a Class I device regulated under 21 CFR 868.5220. B & F Medical Products, Inc. has at least 10 other 510(k) clearances on record.