OPHTHASONIC A-SCAN/ B-SCAN

OPHTHASONIC A-SCAN/ B-SCAN is an FDA 510(k)-cleared medical device (K871536) manufactured by Teknar, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 25, 1987. Regulation: 8.