AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR

AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR is an FDA 510(k)-cleared medical device (K971492) manufactured by Bei Medical Systems Co., 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 September 4, 1997. Regulation: 8.