INFUSSION ALARM SYSTEM I.A.S. CAT.#1118

INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 is an FDA 510(k)-cleared medical device (K802011) manufactured by Pollak (Intl.), Ltd.. 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 30, 1980. Regulation: 8.