INFORMED REMOTE FIELD UNIT MODEL IFM1000

INFORMED REMOTE FIELD UNIT MODEL IFM1000 is an FDA 510(k)-cleared medical device (K821712) manufactured by Burditt & Calkins-Siemens-Elema. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 25, 1982. Regulation: 8.