510(k) K861435

BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE by The John Bunn Co. — Product Code CAW

K861435 is an FDA 510(k) premarket notification submitted by The John Bunn Co. for the device "BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE". The FDA issued a decision of Substantially Equivalent on November 7, 1986. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. The John Bunn Co. has at least 10 other 510(k) clearances on record.