510(k) K904748

TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100 by Transtracheal Systems — Product Code DRG

K904748 is an FDA 510(k) premarket notification submitted by Transtracheal Systems for the device "TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100". The FDA issued a decision of Substantially Equivalent on March 1, 1991. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. Transtracheal Systems has at least 7 other 510(k) clearances on record.