About This 510(k) Submission
K980906 is an FDA 510(k) clearance for the TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO, a System, Hemodialysis, Access Recirculation Monitoring (Class II — Special Controls, product code MQS), submitted by Transonic Systems, Inc. (Ithaca, US). The FDA issued a Cleared decision on October 6, 1998, 210 days after receiving the submission on March 10, 1998. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.