510(k) K981078

TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000 by Transtracheal Systems — Product Code CAW

K981078 is an FDA 510(k) premarket notification submitted by Transtracheal Systems for the device "TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000". The FDA issued a decision of Substantially Equivalent on July 23, 1998. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Transtracheal Systems has at least 7 other 510(k) clearances on record.