TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100

TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100 is an FDA 510(k)-cleared medical device (K904748) manufactured by Transtracheal Systems. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 28, 1991. Regulation: 8.