510(k) K904749

TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200 by Transtracheal Systems — Product Code DRQ

K904749 is an FDA 510(k) premarket notification submitted by Transtracheal Systems for the device "TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200". The FDA issued a decision of Substantially Equivalent on March 1, 1991. The device falls under product code DRQ (Amplifier And Signal Conditioner, Transducer Signal), a Class II device regulated under 21 CFR 870.2060. Transtracheal Systems has at least 7 other 510(k) clearances on record.