3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000

3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000 is an FDA 510(k)-cleared medical device (K980089) manufactured by Valley West, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 23, 1998. Regulation: 8.