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Goldway Us, Inc.
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GOLDWAY PATIENT MONITOR, MODEL # UT4000F is an FDA 510(k)-cleared medical device (K021154) 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 April 10, 2003. Regulation: 8.