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Goldway (Us), Inc.
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COMEN MULTI-PARAMETER PATIENT MONITOR is an FDA 510(k)-cleared medical device (K112877) manufactured by Goldway (Us), Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 6, 2012. Regulation: 8.