ZEISS OPMI L STEREO-LAPAROSCOPE

ZEISS OPMI L STEREO-LAPAROSCOPE is an FDA 510(k)-cleared medical device (K931478) manufactured by Carl Zeiss, 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 27, 1994. Regulation: 8.