INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES

INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES is an FDA 510(k)-cleared medical device (K062457) manufactured by Baxter Healthcare Corporation. 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 20, 2006. Regulation: 8.