
Transonic Systems, Inc.
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TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO is an FDA 510(k)-cleared medical device (K980906) manufactured by Transonic Systems, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 5, 1998. Regulation: 8.