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Itamar Medical (C.M.) 1997 , Ltd.
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SLEEP PAT 200 DEVICE is an FDA 510(k)-cleared medical device (K010156) 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 June 18, 2002. Regulation: 8.