510(k) K990678

PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC) by Salter Labs — Product Code NFB

K990678 is an FDA 510(k) premarket notification submitted by Salter Labs for the device "PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC)". The FDA issued a decision of Substantially Equivalent on May 7, 1999. The device falls under product code NFB (Conserver, Oxygen), a Class II device regulated under 21 CFR 868.5905. Salter Labs has at least 10 other 510(k) clearances on record.