ZURA TEE SYSTEM WITH CLARITEE PROBE

ZURA TEE SYSTEM WITH CLARITEE PROBE is an FDA 510(k)-cleared medical device (K100989) manufactured by Imacor, 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 June 24, 2010. Regulation: 8.