SOUNMED COLOPOSCOPE COLPO-99/99PLUS

SOUNMED COLOPOSCOPE COLPO-99/99PLUS is an FDA 510(k)-cleared medical device (K070845) manufactured by Sounmed, 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 October 11, 2007. Regulation: 8.