VOLUMETRIC PUMP SOLUTION SET FOR FLO-GARD 8000

VOLUMETRIC PUMP SOLUTION SET FOR FLO-GARD 8000 is an FDA 510(k)-cleared medical device (K893716) manufactured by Baxter Healthcare 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 September 17, 1989. Regulation: 8.