510(k) K982943

TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000 by Transtracheal Systems — Product Code NFB

K982943 is an FDA 510(k) premarket notification submitted by Transtracheal Systems for the device "TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000". The FDA issued a decision of Substantially Equivalent on July 12, 1999. The device falls under product code NFB (Conserver, Oxygen), a Class II device regulated under 21 CFR 868.5905. Transtracheal Systems has at least 7 other 510(k) clearances on record.