FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01

FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01 is an FDA 510(k)-cleared medical device (K003582) manufactured by Fluidsense Corp.. 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 December 4, 2000. Regulation: 8.