ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100

ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100 is an FDA 510(k)-cleared medical device (K051413) manufactured by Avent America, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 28, 2005. Regulation: 8.