PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER)

PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER) is an FDA 510(k)-cleared medical device (K903457) manufactured by Precise Optics. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 18, 1990. Regulation: 8.