NORDISK INFUSER SYSTEM WITH PRE-FILLED CARTRIDGE

NORDISK INFUSER SYSTEM WITH PRE-FILLED CARTRIDGE is an FDA 510(k)-cleared medical device (K860492) manufactured by Nordisk Infuser System. 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 February 18, 1986. Regulation: 8.