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Itamar Medical
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WATCH-PAT 200I (WP200I) is an FDA 510(k)-cleared medical device (K081037) manufactured by Itamar Medical. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 8, 2008. Regulation: 8.