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Parama-Tech Company., Ltd.
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PALM ECG RECORDER, MODEL EP-201/202 is an FDA 510(k)-cleared medical device (K061123) manufactured by Parama-Tech Company., Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 28, 2007. Regulation: 8.