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Fukuda Denshi USA, Inc.
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FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE is an FDA 510(k)-cleared medical device (K013273) manufactured by Fukuda Denshi USA, 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 December 19, 2001. Regulation: 8.