
Nihon Kohden America, Inc.
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WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES is an FDA 510(k)-cleared medical device (K002473) 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 November 7, 2000. Regulation: 8.