WATCH-PAT 100

WATCH-PAT 100 is an FDA 510(k)-cleared medical device (K010739) manufactured by Itamar Medical (C.M.) 1997 , 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 November 5, 2001. Regulation: 8.