GC-3000E DIGITAL COLPOSCOPE

GC-3000E DIGITAL COLPOSCOPE is an FDA 510(k)-cleared medical device (K122311) manufactured by Shenzhen Goldcare Meditech Co., Ltd.. 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 September 17, 2013. Regulation: 8.