IV SETS 2000 SERIES (HS-200,2L0,220)

IV SETS 2000 SERIES (HS-200,2L0,220) is an FDA 510(k)-cleared medical device (K761327) manufactured by Extracorporeal Medical Specialities, 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 January 30, 1977. Regulation: 8.