WATCH-PAT200U (WP200U)

WATCH-PAT200U (WP200U) is an FDA 510(k)-cleared medical device (K133859) manufactured by Itamar Medical , Ltd.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 29, 2014. Regulation: 8.