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Nihon Kohden America, Inc.
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ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M is an FDA 510(k)-cleared medical device (K072217) manufactured by Nihon Kohden America, 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 August 29, 2007. Regulation: 8.