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Nihon Kohden America, Inc.
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NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P is an FDA 510(k)-cleared medical device (K083456) manufactured by Nihon Kohden America, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 1, 2009. Regulation: 8.