DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9)

DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9) is an FDA 510(k)-cleared medical device (K093332) manufactured by Delphi Medical Systems. 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 8, 2009. Regulation: 8.