OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340)

OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340) is an FDA 510(k)-cleared medical device (K963333) manufactured by Karl Storz Imaging, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 21, 1996. Regulation: 8.