GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE

GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE is an FDA 510(k)-cleared medical device (K083019) manufactured by Hospira, 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 October 21, 2008. Regulation: 8.